1.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.
2.CT-based multi-regional radiomics for predicting radiation pneumonitis in lung cancer patients
Binghua LIANG ; Jianwei SUN ; Honglin CHEN ; Tao ZHANG ; Heng ZHANG ; Xinye NI
Chinese Journal of Medical Physics 2025;42(8):1011-1017
Objective To establish a reliable prediction model for radiation pneumonitis(RP)based on multi-regional radiomics analysis of localizable CT images.Methods A retrospective analysis was conducted on 185 patients who received radiotherapy from January 2021 to June 2023 in the Department of Radiotherapy,Xuzhou Cancer Hospital.Patients were classified as having RP or not based on imaging combined with clinical diagnosis.Three regions of interest(ROI)were defined in the localizable CT images:Lung,Lung-PTV and PTV,and their radiomics features were extracted.After feature screening using methods such as Mann-Whitney Utest,recursive feature elimination,and Lasso,a prediction model was established using support vector machine classification algorithm.The model performance was validated using 6 evaluation metrics:the area under the receiver operating characteristic curve(AUC),accuracy,specificity,sensitivity,positive predictive value,and negative predictive value.Results The prediction model consisted of 7 radiomics features.The clinical model of target-to-lung ratio,PTV model,Lung model,and Lung-PTV model achieved AUC values of 0.535,0.801,0.672,and 0.706 in the test set,respectively.The AUC value and accuracy of PTV model reached 0.843 and 0.775 in the training set,while 0.801 and 0.750 in the test set.PTV model was superior to Lung model,Lung-PTV model,and clinical model in predictive performance.The AUC values of the combined PTV+(Lung-PTV)model in the training and test sets were 0.867 and 0.806,respectively,higher than those of PTV model and Lung-PTV model.Conclusion The predictive ability of the prediction models constructed from radiomics features in different ROI for symptomatic RP varies.The radiomics prediction model using PTV as ROI exhibits superior predictive performance,and the combined multi-regional radiomics model can further improve the predictive ability for RP.
3.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.
4.CT-based multi-regional radiomics for predicting radiation pneumonitis in lung cancer patients
Binghua LIANG ; Jianwei SUN ; Honglin CHEN ; Tao ZHANG ; Heng ZHANG ; Xinye NI
Chinese Journal of Medical Physics 2025;42(8):1011-1017
Objective To establish a reliable prediction model for radiation pneumonitis(RP)based on multi-regional radiomics analysis of localizable CT images.Methods A retrospective analysis was conducted on 185 patients who received radiotherapy from January 2021 to June 2023 in the Department of Radiotherapy,Xuzhou Cancer Hospital.Patients were classified as having RP or not based on imaging combined with clinical diagnosis.Three regions of interest(ROI)were defined in the localizable CT images:Lung,Lung-PTV and PTV,and their radiomics features were extracted.After feature screening using methods such as Mann-Whitney Utest,recursive feature elimination,and Lasso,a prediction model was established using support vector machine classification algorithm.The model performance was validated using 6 evaluation metrics:the area under the receiver operating characteristic curve(AUC),accuracy,specificity,sensitivity,positive predictive value,and negative predictive value.Results The prediction model consisted of 7 radiomics features.The clinical model of target-to-lung ratio,PTV model,Lung model,and Lung-PTV model achieved AUC values of 0.535,0.801,0.672,and 0.706 in the test set,respectively.The AUC value and accuracy of PTV model reached 0.843 and 0.775 in the training set,while 0.801 and 0.750 in the test set.PTV model was superior to Lung model,Lung-PTV model,and clinical model in predictive performance.The AUC values of the combined PTV+(Lung-PTV)model in the training and test sets were 0.867 and 0.806,respectively,higher than those of PTV model and Lung-PTV model.Conclusion The predictive ability of the prediction models constructed from radiomics features in different ROI for symptomatic RP varies.The radiomics prediction model using PTV as ROI exhibits superior predictive performance,and the combined multi-regional radiomics model can further improve the predictive ability for RP.
5.Discussion on Etiology and Pathogenesis of Recurrent Spontaneous Abortion Caused by Immune Factors Based on"Latent Toxic Hiding in Membrane"
Minghui YUAN ; Jianwei ZHANG ; Liang ZHANG ; Yuanhang RONG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(2):16-20
Immune factors play an important role in recurrent spontaneous abortion(RSA),and immune imbalance affects embryo implantation,growth,and development.There is currently no consensus on the etiology and pathogenesis of RSA caused by immune factors.Based on the theory of latent toxic in TCM and combined with the pathological mechanism of the dynamic changes of immune abnormal substances in the body,this article proposed that latent toxic is the key cause of RSA caused by immune factors.Furthermore,it expounded the pathogenic characteristics of latent toxic:combination of heat and blood stasis hidden in the womb,and latent toxic plays a role in embryo formation under qi deficiency conditions.It is established that latent toxin stagnation in the membrane is the pathogenic mechanism.Moreover,this article revealed the variable pathological changes such as the blockage of the inner membrane system and the outer membrane system.Treatment should be based on the basic methods of tonifying qi and nourishing blood,tonifying kidney to secure the Thoroughfare Vessel,clearing heat and cooling blood,promoting blood circulation and removing blood stasis.This article could provide a theoretical basis for TCM syndrome differentiation and treatment of RSA caused by immune factors.
6.Effect of miR-26b on proliferation,migration and osteogenic differentiation of stem cells from human exfoliated deciduous teeth and human umbilical cord mesenchymal stem cells
Yuanyuan YUAN ; Lu PAN ; Shaolan ZHOU ; Yan LIANG ; Jianwei XU ; Wen XU
Chinese Journal of Tissue Engineering Research 2024;28(13):2017-2023
BACKGROUND:microRNA-26b(miR-26b)plays an important regulatory role in a variety of stem cell functions,but its effects on the biological properties of stem cells from human exfoliated deciduous teeth and human umbilical cord mesenchymal stem cells are unknown. OBJECTIVE:To investigate the effects of miR-26b on the proliferation,migration and osteogenic differentiation of stem cells from human exfoliated deciduous teeth and human umbilical cord mesenchymal stem cells. METHODS:Stem cells from human exfoliated deciduous teeth and human umbilical cord mesenchymal stem cells were cultured and identified.miR-26 mimics(experimental group)and miRNAs mimics control(control group)were used to transfect above mentioned two kinds of cells and construct overexpressed models for subsequent experiments.CCK-8 assay was applied to detect the proliferation ability of overexpressed miR-26b cells.Transwell and scratch assay were employed to analyze the migration ability of overexpressed miR-26b cells.RT-qPCR was utilized to examine the expression of osteogenic markers after osteogenic induction of overexpressed miR-26b cells. RESULTS AND CONCLUSION:(1)Transfection of miR-26b mimics increased miR-26b expression in the two kinds of cells and promoted the proliferation of stem cells from human exfoliated deciduous teeth,with no significant effect on the amplification of human umbilical cord mesenchymal stem cells.(2)Compared with the control group,the migration ability was enhanced after two types of cells overexpressing miR-26b.(3)miR-26b expression decreased during osteogenic differentiation of the two kinds of cells.(4)Compared with the control group,the levels of osteogenesis-related genes osteocalcin,osteopontin,alkaline phosphatase,and human type I collagen mRNA were downregulated after overexpression of miR-26b in the two kinds of cells.The results showed that overexpression of miR-26b promoted the proliferation and migration of stem cells from human exfoliated deciduous teeth and inhibited their osteogenic differentiation;it promoted the migration of human umbilical cord mesenchymal stem cells and inhibited their osteogenic differentiation,but had no significant effects on their proliferation.
7.Progress of research on health effects and healthy risk assessment of ionizing radiation
Bo TANG ; Jianwei LIU ; Chuansheng DU ; Liang SUN ; Yu TU
Chinese Journal of Radiological Health 2024;33(2):221-228
Occupational exposure to ionizing radiation represents a critical factor contributing to health risks in workplaces. Previous experimental and clinical studies have demonstrated that ionizing radiation affects human health. Therefore, scientific assessment of health risk caused by ionizing radiation and effective protection against ionizing radiation are of great importance to formulate the preventive interventions against occupational exposure to ionizing radiation. This review summarizes the advances in the research on health effects, health risk assessment methods, and protective interventions of ionizing radiation. We call for research on the health effects of low-dose radiation, individual difference, and optimization of preventive strategies. In addition, improved mechanisms of health monitoring, periodical healthy examinations, and monitoring of radiation doses should be implemented. Moreover, strict compliance to operating procedures and occupational preventive interventions are recommended. These measures aim to minimize the potential harmlessness of occupational exposure to ionizing radiation, thereby safeguarding the health and safety of individuals exposed to ionizing radiation.
8.Special Bosworth fractures: a case report and literature review
Liang ZHANG ; Jianhua FU ; Yiyang LIU ; Zhaohui WANG ; Jianwei LIU
Chinese Journal of Orthopaedics 2024;44(18):1233-1238
This study details a rare instance of a high fibula fracture, classified as a Bosworth fracture. A 54-year-old male presented with pain and restricted movement in his right ankle after a sprain that occurred 10 hours ago. After initial assessments he was diagnosed as a right ankle fracture with posterior dislocation, a proximal right fibula fracture, and an injury to the right lower tibiofibular joint. According to Lauge-Hansen classification this was a type IV injury charactered by pronation-external rotation. Attempts at manual reduction were unsuccessful. Further evaluation using CT scans with three-dimensional reconstruction showed a separation and dislocation at the lower tibiofibular joint, with the distal fibula interlocked with the posterolateral tibia. Additionally, comminuted fractures of the medial and posterior malleoli showed significant displacement and misalignment, leading to persistent ankle dislocation. Immediate calcaneal traction and symptomatic treatment were applied. On the third day of admission a reevaluation indicated successful reduction of the dislocated ankle and tibiofibular joint. Surgery was then performed with favorable outcome. Follow-up X-rays at one and a half years after surgery demonstrated bony heal of the fractures with normal ankle joint space and functionality. Bosworth fractures involving pronation-external rotation are notably less common than those with posterior-external rotation. When manual reduction proves ineffective, applying continuous calcaneal traction with gradual tension can help unlock fibular dislocation, thereby expediting surgical intervention.
9.Progress of immunocellular therapy in treatment of IBD
Jianwei ZHOU ; Zhe ZHANG ; Xia LIU ; Yaxing SUN ; Liang WANG ; Baisui FENG
Chinese Journal of Immunology 2024;40(6):1324-1328
Inflammatory bowel disease(IBD)is a disease characterized by chronic,recurrent intestinal inflammation,includ-ing Crohn's disease(CD)and ulcerative colitis(UC).Etiology and pathogenesis of IBD are unknown,and the treatment is difficult.In recent years,immunocellular therapy represented by regulatory T(Treg)cell therapy and dendritic cell(DC)therapy has developed rapidly in the field of immune-related disease treatment,and some progress has also been made in the treatment of IBD.This review will introduce application and progression of Treg cell therapy and DC therapy in IBD treatment.
10.Research on the effect of disposable electronic soft mirror and conventional repeatable soft mirror on the renal function as well as trauma degree in patients with upper ureteral calculi and factors risk for postoperative recurrence
Min YU ; Qiang LI ; Donghong HUANG ; Gang YU ; Jian BAI ; Jianwei LI ; Jianhui ZHENG ; Sizhong LIANG ; Yaoguang HUANG
China Journal of Endoscopy 2024;30(7):31-38
Objective To explore the effect of disposable electronic soft mirror and conventional repeatable soft mirror on the renal function and prostaglandin E2(PGE2),5-hydroxytryptamine(5-HT)levels in patients with upper ureteral calculi and analyze the factors influencing recurrence after retrograde intrarenal surgery(RIRS).Methods 114 patients with upper ureteral calculi from March 2022 to March 2023 were selected and randomly divided into two groups,with 57 cases forming the observation group and 57 cases forming the control group.The observation group was administrated with RIRS via disposable electronic soft mirror,while the control group accepted RIRS via conventional repeatable soft mirror.The two groups were compared in the aspect of surgical data.Patients'serum renal function indicators[blood urea nitrogen(BUN),creatinine(Cr),cystatin C(CysC)],PGE2 and 5-HT levels were tested preoperative and postoperative 24 h.Postoperative complications and recurrence were compared between the two groups after 6 months follow-up.The patients were grouped according to whether there was recurrence or not.The medical records of recurrence group and non-recurrence group were collected,and the risk factors of recurrence were analyzed statistically.Results There was no sxtatistically significant difference between the observation group and the control group in terms of surgical time,intraoperative bleeding,one-time stone removal rate,and hospital stay(P>0.05).After operation both groups saw much higher levels of BUN,Cr,CysC,PGE2 and 5-HT than they did before the operation(P<0.05),but no significant difference in the aforementioned indicators was seen between the two groups either before or after the operation(P>0.05).The incidence of complications and recurrence rate of the observation group were 3.51%and 15.79%respectively,seeing no big difference from 12.28%and 21.05%of the control group(P>0.05).The body mass index(BMI),postoperative residual calculi and urinary tract infections in the recurrence team were remarkably higher than those in the non recurrence team(P<0.05).The results of multivariate Logistic regression analysis showed that after adjusting for confounding factors such as gender,age,course of disease,maximum diameter of calculi,number of calculi,location of calculi,and surgical method,postoperative residual calculi and postoperative urinary tract infections were independent risk factors for postoperative recurrence of upper ureteral calculi after RIRS(P<0.05).Conclusion Both disposable electronic soft endoscopy and conventional repeatable soft endoscopy can achieve satisfactory results in the treatment of upper ureteral calculi,both can impact the renal function and serum PGE2,5-HT levels in patients to a certain extent,and both present a risk of recurrence after surgery.Residual postoperative calculi and postoperative urinary tract infections are independent risk factors inducing recurrence of upper ureteral calculi after RIRS.

Result Analysis
Print
Save
E-mail