1.Clinical Efficacy and Radiographic Outcomes of Manipulative Reduction Combined with Small Splint Fixation for Distal Radius Fractures:A Retrospective Multicenter Study with Propensity Score Matching
Mao WU ; Guoda DAI ; Yang SHAO ; Shaoshuo LI ; Zhen HUA ; Hengyan CUI ; Tingchen ZHU ; Dipeng LI ; Jintao LIU ; Ming ZHOU ; Peimin WANG ; Liyong ZHANG ; Jianwei WANG
Journal of Traditional Chinese Medicine 2026;67(10):1086-1092
ObjectiveTo observe the clinical efficacy and radiographic outcomes of manipulative reduction combined with small splint fixation in the treatment of distal radius fractures. MethodsThe clinical data of 1051 patients with distal radius fractures were retrospectively collected from five hospitals included in the Jiangsu Diagnosis and Treatment Data Platform for Traditional Chinese Medicine(TCM) Dominant Diseases. Propensity score matching at a 1∶4 ratio was applied, resulting in 580 cases selected for final analysis, which comprised 448 patients in the TCM group(manipulative reduction plus small splint fixation) and 132 in the surgical treatment group(open reduction and internal fixation). Each group was further stratified into type A, B, and C subgroups based on AO fracture classification. Radiographic indicators including palmar tilt, radial inclination, and radial height were compared between groups before treatment and 1 day, 1 week, and 4-6 weeks after treatment, and pain visual analog scale(VAS) scores before treatment and 1 week and 4-6 weeks after treatment were also compared. Wrist joint function was assessed 12 weeks after treatment, using the Dienst wrist function score and the Gartland and Werley(G-W) wrist function score. Additionally, the radiographic indicators at different timepoints and the 12-week wrist function levels were compared between groups across different fracture types. ResultsNo statistically significant difference was observed in radiographic indicators and VAS scores at all timepoints before and after treatment, as well as wrist joint function grades assessed by the Dienst score and the G-W score at 12 weeks after treatment (P>0.05). Compared to those before treatment, both groups showed increased palmar tilt, radial inclination, and radial height 1 week and 4-6 weeks after treatment, and decreased VAS scores (P<0.05). Compared to those 1 week after treatment, both groups showed a decrease in palmar tilt, an increase in radial inclination and radial height, and a reduction in VAS score 4-6 weeks after treatment(P<0.05). In type A and B subgroups, the surgical treatment group had a higher radial inclination than the TCM group 4-6 weeks after treatment, while in the type C subgroup, a higher radial height was shown in the surgical treatment group than in the TCM group 4-6 weeks after treatment(P<0.05). In type C subgroup, there was significant difference between groups in the wrist joint function by G-W scores 12 weeks after treatment(P<0.05). ConclusionManipulative reduction combined with small splint fixation can maintain fracture alignment and alleviate pain in treating distal radius fractures, which achieves therapeutic outcomes comparable to surgical treatment. It is particularly suitable for type A and B fractures and can be considered an effective treatment option for distal radius fractures.
2.Construction and Clinical Validation of a Deep Learning-Based Automatic Measurement Model for Palmar Tilt and Radial Inclination in Distal Radius Fractures
Guoda DAI ; Jianwei WANG ; Mao WU ; Bin KANG ; Yang SHAO ; Hengyan CUI ; Shaoshuo LI ; Tingchen ZHU ; Zhen HUA ; Zhongming SHEN ; Jintao LIU ; Ming ZHOU
Journal of Traditional Chinese Medicine 2026;67(10):1093-1100
ObjectiveTo construct an automatic measurement model for palmar tilt and radial inclination suitable for traditional Chinese medicine (TCM) clinical scenarios, and to validate its accuracy and efficiency in TCM manipulative reduction settings. MethodsData on anteroposterior (AP) and lateral X-rays of distal radius fractures were collected from patients admitted to 18 TCM/ integrated TCM and western medicine hospitals in Jiangsu province between September 1st, 2023, and September 1st, 2024, via the Jiangsu Diagnosis and Treatment Big Data Platform for TCM Dominant Diseases. A medical image segmentation framework based on multi-scale feature fusion and edge-awareness was employed, combined with anatomical knowledge specific to TCM orthopedics, to optimize the feature extraction strategy of an artificial intelligence (AI) model. This framework enabled automatic segmentation of fracture regions and measurement of distal radius palmar tilt and radial inclination. The accuracy of the AI model in measuring radial inclination and volar tilt was validated, and the measurement time and average time gain rate of the AI model were compared to those of manual measurement. ResultsA total of 15,444 AP and lateral X-ray images of distal radius fractures were collected, and were divided into a training set (11,144 images, 5066 AP and 6078 lateral), a validation set (3700 images, 1840 AP and 1860 lateral), and an independent test set (600 images, 300 AP and 300 lateral) after preprocessing. In the measurement of 300 AP X-rays in the independent test set for radial inclination, when the degree error between AI measurement and manual measurement was <3° and <5°, AI measurement accuracy was 83% and 93%, respectively. In 300 lateral X-rays in the test set for palmar tilt, when AI measurements had an error of <3° and <5° compared to manual measurements, corresponding accuracy rate was 78% and 90%, respectively. For 50 X-ray images, AI measurement time was (1.37±0.05) min for radial inclination while manual measurement time was (22.57±2.52) min (P<0.001); in terms of palmar tilt, the AI measurement time was (1.33±0.14) min, shorter than (23.70±2.80) min for manual measurement time (P<0.001). Average time gain rates for manual and AI measurements were 93.93% and 94.39% respectively. ConclusionAn automatic measurement model for palmar tilt and radial inclination in distal radius fractures has been established, enabling more accurate and efficient assessment as well as providing a tool to support the quantitative evaluation of the efficacy of TCM manipulative reduction and large-sample clinical research.
3.Assessment of the clinical application of optical navigation technology for precise puncture in sacral neuromodulation surgery?
Ziqin ZHOU ; Xin SONG ; Tingting LYU ; Weilin FANG ; Jin HUANG ; Bo WANG ; Jianwei LYU
Chinese Journal of Urology 2025;46(9):653-660
Objective:To explore the clinical application value of optical navigation system(ONS)-guided sacral neuromodulation(SNM)electrode implantation for precise puncture.Methods:?This study was a randomized,controlled trial. Patients who underwent SNM electrode implantation at the Gongli Hospital,Pudong New Area,Shanghai,from February 2024 to March 2025 were included. Inclusion criteria:aged 18?80 years,meeting the indications recommended by the Chinese expert consensus on the clinical application of sacral neuromodulation or expanded applications,and having completed pelvic CT and MRI examinations to ensure image quality for navigation system use. Exclusion criteria:progressive neurological diseases,severe urinary tract infections,urinary tract obstruction,or other conditions that may affect surgical outcomes and safety. Patients were randomly divided into two groups using a random number table and a single-blind design was implemented. The two groups underwent different puncture guidance methods in the stage Ⅰ surgery,but other treatments and follow-up measures were consistent.The experimental group used ONS-guided puncture with preoperative pelvic CT and MRI scans for multimodal image fusion and 3D reconstruction and software-based puncture path planning for real-time intraoperative guidance. The control group used X-ray-guided cross-positioning,determining the S3 sacral foramen for puncture based on anatomical landmarks with a metal positioning ruler under fluoroscopy. The puncture path was planned using software to achieve real-time intraoperative guidance. Intraoperative indicators(number of punctures,puncture time,electrode contact points,minimum effective voltage,X-ray fluoroscopy time,radiation dose,total surgical time)and postoperative outcomes(complications,pain scores,stage Ⅱ permanent implantation rates)were compared between the two groups to assess the advantages and feasibility of ONS-guided sacral nerve electrode implantation.Results:?A total of 35 patients were included in each group. The experimental group had fewer intraoperative puncture attempts[2.0(2.0,3.0)vs. 5.0(4.0,7.0)]and shorter puncture procedure time[7.5(6.0,10.0)min vs. 14.0(12.0,18.0)min],indicating more accurate and efficient ONS-guided puncture. There was no statistical difference in the number of electrode contact points between the two groups[3.0(3.0,4.0)vs. 3.0(3.5,3.8), P = 0.374],but the experimental group had a lower effective voltage[1.8(1.8,2.5)V vs. 2.5(1.8,3.0)V]and shorter stimulator adjustment time[10.0(8.0,12.0)min vs. 16.0(13.0,20.0)min]. The experimental group had shorter intraoperative X-ray fluoroscopy time[1.6(1.1,2.2)min vs. 4.6(3.8,6.0)min],lower radiation dose[165.8(107.6,205.3)mGy vs. 427.4(325.1,636.5)mGy],shorter total surgical time[52.0(49.0,57.8)min vs. 68.0(62.0,74.0)min],less intraoperative blood loss[4.0(4.0,5.0)ml vs. 6.0(5.0,7.0)ml],and a lower proportion of patients requiring supplemental local anesthesia[14.3%(5/35)vs. 40.0%(14/35)]. The postoperative wound infection rates were not statistically different between the two groups[0 vs. 2.9%(1/35), P = 1.000],but the experimental group had significantly lower pain scores on postoperative day 1[(1.9 ± 1.1)vs.(3.2 ± 1.4)]and a higher stage Ⅱ permanent implantation rate[85.7%(30/35)vs. 65.7%(23/35)],with statistically significant differences( P < 0.05). Conclusions:?ONS-guided SNM electrode implantation reduces the number of puncture attempts,surgical time,and X-ray radiation,effectively lowers the effective voltage,and increases the stage Ⅱ permanent implantation rate.
4.Deer antler stem cell exosome composite hydrogel promotes the repair of burned skin
Jianwei ZHAO ; Xunsheng LI ; Jinpeng LYU ; Jue ZHOU ; Yidi JIANG ; Zhigang YUE ; Hongmei SUN
Chinese Journal of Tissue Engineering Research 2025;29(34):7344-7352
BACKGROUND:The study of deer antler stem cells and exosomes to promote the repair of acute skin injuries has received increasing attention in recent years,but the effect and mechanism of exosomes composite hydrogel to promote the repair of burn wounds are still unclear.OBJECTIVE:To investigate the effect of deer antler stem cell exosome composite hydrogel on the healing speed and quality of rat deep third-degree burn wound and its mechanism of action.METHODS:Deer antler stem cell exosomes and bone marrow mesenchymal stem cell exosomes were extracted and compounded with Pluronic F-127 to prepare a temperature-sensitive hydrogel.A constant temperature and pressure burn apparatus was used to prepare a rat model of deep third-degree burn.The drug was administered to four groups:deer antler stem cell exosome composite hydrogel group,bone marrow mesenchymal stem cell exosome composite hydrogel group,human epidermal growth factor gel group,and the control group.The healing of burned rats was observed and the wound healing rate was calculated.At 28 days after burn,hematoxylin-eosin staining was used to observe the generation of skin accessory structures in the healing tissues.Masson staining was used to analyze the accumulation of collagen in the healing tissues.Immunohistochemistry was used to examine the angiogenesis and nflammatory response in the healing tissues.qRT-PCR was used to examine the expression level of mRNA of the wound healing-related genes in the healing tissues.RESULTS AND CONCLUSION:(1)Deer antler stem cell exosome composite hydrogel can significantly promote the healing rate of deep burn wounds in rats,and improve the quality of wound healing by promoting the regeneration of skin collateral structures,increasing the dermal thickness and enhancing the accumulation of collagen.(2)The number of myofibroblasts in the wound healing tissues of deer antler stem cell exosome composite hydrogel group was significantly reduced,and the number of neovascularization and M2 macrophages was significantly increased.(3)The mRNA levels of transforming growth factor β3 and type Ⅲ collagen in the wound healing tissue of deer antler stem cell exosome composite hydrogel group were significantly higher than those of the blank group,and the mRNA levels of transforming growth factor β1,matrix metalloproteinase 3,and type Ⅰ collagen were significantly lower than those of the blank group,and there was no significant difference between the bone marrow-derived mesenchymal stem cell exosome composite hydrogel group and the human epidermal growth factor gel group.In conclusion,deer antler stem cell exosome composite hydrogel can promote the healing speed and the quality of healing of deep burned wounds in rats,which may be achieved by inhibiting fibroblastogenesis,promoting angiogenesis,macrophage M2 polarization,and regulating the expression of genes for collagen production/degradation.
5.A clinical research of endoscopic submucosal dissection for ileocecal valve lipoma
Shaobin LUO ; Li WANG ; Keyang FAN ; Zuqiang LIU ; Hao HU ; Wenzheng QIN ; Zhen ZHANG ; Mingyan CAI ; Jianwei HU ; Lili MA ; Yiqun ZHANG ; Yunshi ZHONG ; Quanlin LI ; Pinghong ZHOU
Chinese Journal of Digestive Endoscopy 2025;42(6):469-473
Objective:To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) for the treatment of ileocecal valve lipoma.Methods:A retrospective cohort study was performed on data of ileocecal lipoma patients who underwent ESD at the Endoscopy Center of Zhongshan Hospital, Fudan University from December 2013 to June 2023. According to the lesion location, the patients were divided into ileocecal valve group and cecum group. The operation time, operation speed, en bloc resection rate, complications, and follow-up outcomes between the two groups were compared.Results:A total of 59 patients with ileocecal lipoma were enrolled, including 31 patients in the ileocecal valve group and 28 patients in the cecum group.There were no significant differences in gender, age, specimen size, or lesion size between the two groups ( P>0.05). Lipomas in both the ileocecal valve group and the cecum group were successfully resected by ESD. The en bloc resection rates were 100.0% (31/31) and 92.9% (26/28) respectively, and the difference was not statistically significant ( χ2=0.033, P=0.133). Median operative duration significantly differed between the two groups ( ileocecal valve group 26 min VS cecum group 20 min, Z=-0.136, P=0.027), as did resection speed (ileocecal valve group 0.14 cm2/min VS cecum group 0.24 cm2/min, Z=-0.223, P=0.022). Adverse events included one postoperative fever in the ileocecal valve group and one delayed bleeding in the cecum group. During the median follow-up of 38 months (7-106 months), there was no case of residual tumor or recurrence. Conclusion:Despite technical challenges in ESD of ileocecal valve lipoma, it is still a safe, feasible and effective treatment method.
6.Development and validation of a nomogram for predicting postoperative prognosis in gallbladder cancer patients based on the HALP score
Shujie HE ; Zhelong JIANG ; Lili WU ; Xuanhua LIN ; Lizhi LYU ; Yang CHENG ; Baipo ZHOU ; Fang YANG ; Jianwei CHEN
Chinese Journal of Hepatobiliary Surgery 2025;31(9):666-670
Objective:To analyze the effects of hemoglobin, albumin, lymphocyte and platelet count (HALP) scores on the survival of gallbladder cancer patients after radical surgery, and to construct a prognostic prediction model and evaluate based on HALP scores.Methods:The clinical data of 95 patients with gallbladder cancer who underwent surgical treatment in Fuzong Clinical Medical College of Fujian Medical University (the 900th Hospital) from January 2010 to December 2022 were retrospectively analyzed, including 40 males and 55 females, with the age of (63.3±12.2) years. All patients were divided into a low HALP group (HALP score ≤35.4, n=45) and a high HALP group (HALP score >35.4, n=50) based on the optimal cut-off value of 35.4 for predicting postoperative survival as determined by the receiver operating characteristic (ROC) curve. Survival curves were plotted by the Kaplan-Meier method, and survival comparisons were performed using the log-rank test. Univariate and multivariate Cox regression were used to analyze the effect of HALP score on survival after radical surgery in patients with gallbladder cancer. Based on the multifactorial results, nomogram was constructed to predict the survival of gallbladder cancer patients after radical surgery, and ROC curves, consistency indexes were evaluated in the model. Results:A total of 95 patients were followed up for 1-150 months, with a median of 13 months. The 1-, 3-, and 5-year postoperative cumulative survival rates of patients in the low HALP group were 56.2%, 31.2%, and 11.1%, respectively, which were lower than those of the high HALP group, which were 82.9%, 59.6%, and 40.7%, and the difference was statistically significant ( χ2=12.50, P<0.001). Based on multifactorial Cox regression analysis, preoperative total bilirubin ≥23 μmol/L, with lymph node metastasis, tumor TNM stage Ⅲ-Ⅳ, and postoperative incision infection were the risk factors for survival after radical surgery in patients with gallbladder cancer, and a HALP score of >35.4 and Child-Pugh A were protective factors (all P<0.05). Based on the results of multivariate Cox regression analysis to construct a nomogram for predicting overall survival after radical surgery in patients with gallbladder cancer, the consistency index between the prediction of the nomogram and the actual situation was 0.801 (95% CI: 0.752-0.850), and the area under the ROC curve for predicting overall survival was 0.812 (95% CI: 0.704-0.902). Conclusion:The preoperative high HALP score (HALP > 35.4) is a protective factor for survival after radical surgery in gallbladder cancer patients, and the nomogram constructed based on the HALP score for survival prediction after radical surgery for gallbladder cancer has high accuracy and can be used for the assessment of postoperative survival.
7.Application of real-time virtual sonography combined with intraductal biliary contrast-enhanced ultrasound in percutaneous transhepatic cholangial drainage
Huajun WU ; Jianwei YI ; Zhigang HU ; Binghai ZHOU ; Jiafu GUAN ; Jinlong YAN ; Xin YU ; Rongfa YUAN ; Shubing ZOU ; Kai WANG
Chinese Journal of Surgery 2025;63(8):732-737
Objective:To explore the application value of real-time virtual sonography (RVS) combined with intraductal biliary contrast-enhanced ultrasound (IB-CEUS) in percutaneous transhepatic cholangial drainage (PTCD).Methods:This retrospective cohort study included data from 71 patients who underwent PTCD at the Department of Hepatobiliary and Pancreatic Surgery in the Second Affiliated Hospital of Nanchang University between May 2021 and August 2022. There were 36 male and 35 female patients,aged 35 to 94 years. Based on the guidance modality used,patients were divided into two groups: the RVS combined with IB-CEUS group ( n=36) and the digital subtraction angiography (DSA) group ( n=35). PTCD was performed under the guidance of RVS combined with IB-CEUS in the RVS+IB-CEUS group,and under conventional DSA fluoroscopic guidance in the DSA group. Two clinicians classified the biliary conditions as either simple or complex based on preoperative ultrasound and CT (or MRI) imaging. Statistical analyses were conducted using independent sample t-tests,rank-sum tests, χ2 tests,or Fisher′s exact tests,as appropriate. Results:Significant differences were observed between the RVS+IB-CEUS group and the DSA group in terms of the number of punctures (1.0±0.2 vs. 2.2±1.4, t=-5.148, P<0.01) and postoperative complication rate(2.8% (1/35) vs. 17.1% (6/36), P=0.049). There were 9 patients with complex biliary conditions in the DSA group and 12 in the RVS+IB-CEUS group. The number of punctures in both the simple and complex subgroups of the RVS+IB-CEUS group(1.0±0.2 and 1.0±0.0) remained lower than that in the corresponding DSA subgroups(2.2±1.6 and 2.4±0.4) ( t=-3.606, P<0.01; t=-3.959, P=0.002). Moreover,the complication rate in the simple biliary subgroup of the RVS+IB-CEUS group was significantly lower than that of the DSA group(0 (0/24) vs. 19.2% (5/26), P=0.031),whereas no significant difference was found in the complex biliary subgroup (1/12 vs. 1/9, P=0.686). Conclusion:Guided by RVS and IB-CEUS, PTCD can help reduce the number of punctures during surgery and postoperative complications, and patients with complex bile duct conditions can still benefit from PTCD.
8.Transcatheter aortic valve replacement causing acute cardiac tamponade:clinical analysis of 5 cases
Congle YIN ; Yuchen WEN ; Qing YE ; Jianwei ZHOU ; Zhen FANG ; Daoqian CHEN ; Jun JI ; Bing XU ; Shenghu HE
Journal of Interventional Radiology 2025;34(11):1228-1234
Objective To discuss the causes and the therapeutic strategy of acute cardiac tamponade(ACT)occurring as a complication of transcatheter aortic valve replacement(TAVR)so as to improve the success rate of the surgery and to make a further understanding of this complication.Methods The general clinical data,surgical procedures,and postoperative follow-up results of five patients,who received TAVR at the Affiliated Northern Jiangsu People's Hospital of Yangzhou University of China and developed ACT from March 2018 to September 2024,were retrospectively analyzed.Results After developing ACT,all the 5 patients received pericardiocentesis together with other adjuvant therapies including blood volume expansion with infusion,vasopressors,heparin neutralization,and blood transfusion.However,due to no obvious reduction in drainage volume and unstable hemodynamics all the 5 patients had eventually to receive open-chest surgery to identify the source of bleeding and to make hemostasis.Surgical exploration revealed that the perforation or rupture of cardiac structures caused by the temporary pacemaker lead or a super-stiff guide wire during the procedure was the main cause of ACT.Finally,after active treatment four patients recovered and discharged,and one patient died.The discharged patients were followed up for 3-12 months,and no procedure-related complications such as acute coronary artery occlusion,severe arrhythmia,exacerbation of heart failure symptoms,valve displacement,or stroke occurred.Conclusion As a severe complication occurring during the TAVR procedure,ACT requires to get a rapid diagnosis and management.Improvement of surgical techniques and operative methods,comprehensive preoperative assessment,and close intraoperative monitoring are crucial points for the prevention of ACT.
9.USP20 as a super-enhancer-regulated gene drives T-ALL progression via HIF1A deubiquitination.
Ling XU ; Zimu ZHANG ; Juanjuan YU ; Tongting JI ; Jia CHENG ; Xiaodong FEI ; Xinran CHU ; Yanfang TAO ; Yan XU ; Pengju YANG ; Wenyuan LIU ; Gen LI ; Yongping ZHANG ; Yan LI ; Fenli ZHANG ; Ying YANG ; Bi ZHOU ; Yumeng WU ; Zhongling WEI ; Yanling CHEN ; Jianwei WANG ; Di WU ; Xiaolu LI ; Yang YANG ; Guanghui QIAN ; Hongli YIN ; Shuiyan WU ; Shuqi ZHANG ; Dan LIU ; Jun-Jie FAN ; Lei SHI ; Xiaodong WANG ; Shaoyan HU ; Jun LU ; Jian PAN
Acta Pharmaceutica Sinica B 2025;15(9):4751-4771
T-cell acute lymphoblastic leukemia (T-ALL) is a highly aggressive hematologic malignancy with a poor prognosis, despite advancements in treatment. Many patients struggle with relapse or refractory disease. Investigating the role of the super-enhancer (SE) regulated gene ubiquitin-specific protease 20 (USP20) in T-ALL could enhance targeted therapies and improve clinical outcomes. Analysis of histone H3 lysine 27 acetylation (H3K27ac) chromatin immunoprecipitation sequencing (ChIP-seq) data from six T-ALL cell lines and seven pediatric samples identified USP20 as an SE-regulated driver gene. Utilizing the Cancer Cell Line Encyclopedia (CCLE) and BloodSpot databases, it was found that USP20 is specifically highly expressed in T-ALL. Knocking down USP20 with short hairpin RNA (shRNA) increased apoptosis and inhibited proliferation in T-ALL cells. In vivo studies showed that USP20 knockdown reduced tumor growth and improved survival. The USP20 inhibitor GSK2643943A demonstrated similar anti-tumor effects. Mass spectrometry, RNA-Seq, and immunoprecipitation revealed that USP20 interacted with hypoxia-inducible factor 1 subunit alpha (HIF1A) and stabilized it by deubiquitination. Cleavage under targets and tagmentation (CUT&Tag) results indicated that USP20 co-localized with HIF1A, jointly modulating target genes in T-ALL. This study identifies USP20 as a therapeutic target in T-ALL and suggests GSK2643943A as a potential treatment strategy.
10.Preoperative short-course radiotherapy followed by chemotherapy and PD-1 inhibitor administration for locally advanced rectal cancer: the initial results of a randomized controlled clinical trial (STELLAR II)
Haoyue LI ; Haitao ZHOU ; Lichun WEI ; Yinggang CHEN ; Wenjue ZHANG ; Feiyan DENG ; Ning LI ; Zheng JIANG ; Zheng LIU ; Jianwei LIANG ; Zhaoxu ZHENG ; Xianyu MENG ; Yufei LU ; Zifa LEI ; Xiaoge SUN ; Gong LI ; Yingjie WANG ; Yongwen SONG ; Shunan QI ; Hao JING ; Yirui ZHAI ; Shulian WANG ; Yexiong LI ; Yuan TANG ; Jing JIN
Chinese Journal of Oncology 2025;47(9):913-921
Objectives:To explore whether short-course radiotherapy (SCRT)-based total neoadjuvant therapy (TNT) combined with PD-1 inhibitors could further promote tumor regression and improve the prognosis.Methods:This is a prospective, multicenter, two-arm randomized controlled, seamless phase Ⅱ/Ⅲ trial for proficient mismatch repair or microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC). Eligible patients were randomly assigned to the iTNT (TNT+PD-1) group or the TNT group. Patients in the TNT group received SCRT (5 Gy×5) followed by 4 cycles of CAPOX or 6 cycles of mFOLFOX chemotherapy, with the iTNT group receiving SCRT followed by the same regime in combination with 4 cycles of Sintilimab. Total mesorectal excision (TME) surgery or watch and wait (W&W) was performed after neoadjuvant therapy and then 2 cycles of same regimen as before were recommended. The primary endpoints are the complete response (CR) rate for phase Ⅱ trial and 3-year disease-free survival (DFS) for phase Ⅲ trial. A total of 588 patients will be enrolled for the phase Ⅱ/Ⅲ trial. Short-term efficacy and safety data from the initial 100 treated patients were analyzed as planned.Results:From 2022-8-31 to 2023-5-24 the initial 100 patients were enrolled from 10 hospitals in China, 76.0%(76/100) patients were male, and the median age was 61 years (21-74 years). More patients had tumors located in the lower rectum (78.0%, 78/100), staged T3-4 (97.0%, 97/100) and N1-2 (93.0%, 93/100), and about half of the tumors invaded the mesorectal fascia (52.0%, 52/100) and with extramural vascular invasion (51.0%, 51/100). Analyses were performed according to the per-protocal (PP) set. All patients in the iTNT group ( n=52) and the TNT group ( n=48) completed SCRT; The 4-cycle chemotherapy±Sintilimab completion rates were 86.5% and 100.0% in the iTNT and TNT groups, respectively. In the iTNT group, 82.7% (43/52), 11.5% (6/52), and 5.8% (3/52) of the patients received 4, 3, and 2 cycles of PD-1 inhibitor. After TNT, 68 patients underwent radical surgery and 15 patients achieved cCR and adopted W&W. The pathological complete response (pCR) rates were 48.5% (16/33) and 17.1% (6/35) in the iTNT and TNT groups, with CR rates of 50.0% (25/50) and 26.1% (12/46), respectively. The incidence of treatment-related grade 3-4 adverse events was 26.9% (14/52, iTNT group) and 18.8% (9/48, TNT group), with thrombocytopenia and leukopenia being the most common. Among patients receiving immunotherapy, grade 3 immunotherapy-related adverse events occurred in 2 (3.8%, 2/52) patients: one case was pancreatitis, another case was hepatitis combined with myositis and myocarditis. Conclusion:The preliminary results show that SCRT-based TNT combined with PD-1 inhibitors could further improve the CR rate for LARC without unexpected serious adverse events.

Result Analysis
Print
Save
E-mail