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.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.
3.Research progress in TACE-based combination therapy for primary hepatocellular carcinoma
Zhengfang XIAO ; Youbing ZHENG ; Feiyan DENG ; Siqian ZHENG ; Hongwei SUN ; Yanyan LIU ; Ligong LU
Journal of Interventional Radiology 2024;33(6):688-692
Liver cancer is a prevalent and highly malignant cancer worldwide,with 90%of cases being hepatocellular carcinoma,presenting a significant risk to human health.As early-stage liver cancer often lacks specific manifestations,most patients with liver cancer are already in the middle and late stage of the disease when liver cancer is diagnosed,thus,missing the opportunity for optimal radical treatment.However,the exploration of the treatment for middle and advanced primary hepatocellular carcinoma has never ceased.In recent years,transarterial chemoembolization(TACE)has been included in the standard treatment regimens for primary hepatocellular carcinoma.With the advancement of multidisciplinary comprehensive treatment,various treatment options to reduce the burden of liver cancer lesion with satisfactory therapeutic results have been reported and have been widely used in clinical practice,e.g.hepatic artery infusion chemotherapy(HAIC),targeted therapy,and immunotherapy in combination with TACE,which have significantly improved the overall survival of patients with liver cancer.This paper aims to make a comprehensive review about the latest progress of combination use of TACE and other therapies in reducing tumor burden and improving patient survival in the treatment of primary hepatocellular carcinoma,and to summarize the key issues in combination therapy that require more in-depth research.(J Intervent Radiol,2024,33:688-692)
4.Effects of Liuwei Shunji Capsule on Visceral Hypersensitivity and Content of 5-HT of Rats with Liver Depression and Spleen Deficiency-type Irritable Bowel Syndrome
Guiqiu DENG ; Bei ZHANG ; Zhe ZHANG ; Feiyan CHEN ; Zizhao LAO ; Geng LI ; Qingguang WU ; Honghui CHENG
Chinese Journal of Information on Traditional Chinese Medicine 2014;(8):46-48
Objective To observe the therapeutic effects of Liuwei Shunji Capsule on survival state, visceral hypersensitivity, the content of 5-HT of model rats with liver depression and spleen deficiency-type irritable bowel syndrome (IBS), and explore its mechanism.Methods SD rats were randomly divided into normal group, model group, pinaverium bromide group and Liuwei Shunji Capsule of high, medium and low dose groups. Senna with restraint stress was used in duplicating liver depression and spleen deficiency-type IBS model. From the second day after the model was established, each drug treatment group was administered with corresponding drugs once a day for two weeks. The effects of Liuwei Shunji Capsule on survival state, visceral hypersensitivity, the content of 5-HT in serum and hypothalamus were observed.Results Compared with model group, Liuwei Shunji Capsule could raise weight growth rate of model rats with liver depression and spleen deficiency-type IBS (P<0.05), improve their diarrhea, fatigue demeanor, fur quality, irritability and other symptoms, significantly decrease their visceral hypersensitivity, the content of 5-HT in serum and hypothalamus (P<0.01).Conclusion Liuwei Shunji Capsule can effectively improve survival state and intestinal disorders of rats with liver depression and spleen deficiency-type IBS, and the mechanism of treatment could be realized through regulating 5-HT level.
5.Formula optimization and transfection efficiency of polyethyleneimine/DNA complexes
Feiyan LI ; Jianping ZHOU ; Xiangming WU ; Liye GUAN ; Zuyuan DENG ; Fang XIE
Journal of China Pharmaceutical University 2010;41(1):40-44
Aim: To study the effects of molecule weight,the N/P ratio,solvent and ionic strength on the formation and surface properties of PEI/DNA complexes,and study its transfection efficiency.Methods: The N/P ratio of the prepared PEI/DNA complexes was optimized using gel electrophoresis and UV quantitative assay.The particle size and surface charge of the complexes were measured in different solvents and ionic strength.The transfection effi-ciency in HepG2 cells was observed.Results: There was a positive correlation between combination of PEI and DNA and molecule weight of PEI.In addition,the surface properties of PEI/DNA complexes were also influenced by the solvents and ionic strength.Comparable transfection efficiencies in HepG2 cells were observed for the Lipo-fectamine 2000/DNA and the prepared PEI(25 kD)/DNA complexes in PBS at the N/P ratio of 12-15,which was much higher than that of naked DNA.Conclusion: The optimized PEI/DNA complexes could effeciently transfect the cells in comparison to the positive control.
6.Clinical application of continuous central venous pressure monitoring
Jinwen CHEN ; Zhenglong DU ; Muying ZHOU ; Huan CHEN ; Feiyan DENG ; Guangping ZENG ; Qiyan WANG
Chinese Journal of Practical Nursing 2008;24(15):4-5
Objective To study the clinical effect of continuous central venous pressure monitoring and select a better method for central venous pressure momtoring. Methods Continuous central venous pressure wag monitored by connecting pressure sensor to central venous catheter in 56 patients with open heart operation.At the same time routine monitoring method was used in the same central venous vein of the saine patient The CVP values from the two methods were compared for 100 times and analyzed the difference.Results The VCP values of the two groups had no statistical difference(P>0.05).Conclusions Continuous monitoring by pressure sensor had advantages such as continuous data,dynamic,direct-viewing,Veracious and decreased chance of infection.It could reduce the workload of nurses and possessed more clinical value compared with routine monitoring method.
7.Effects of homocysteine on the expression of macrophage inflammatory protein-1? in cultured human umbilical vein endothelial cells
Shuxiu WANG ; Feiyan ZOU ; Zhongduan DENG ; Zhiling QU ; Juan NI
Chinese Journal of Pathophysiology 1989;0(06):-
AIM: To investigate the effect of homocysteine (HCY) on the induction of macrophage inflammatory protein-1? (MIP-1?) expression in cultured human umbilical vein endothelial cells (HUVECs). METHODS: After exposure of the cultured HUVECs to HCY at increasing concentrations (0.1, 0.5 and 1 mmol/L) for 8 h, the MIP-1? mRNA expression was determined by in situ hybridization using a MIP-1? cDNA probe, and the MIP-1? protein expression was measured by cell enzyme-linked immunosorbent assay (ELISA) using a goat anti-human MIP-1? monoclonal antibody. RESULTS: The in situ hybridization showed that cultured HUVECs were able to express MIP-1? mRNA at a low level that was purplish blue granules in cytoplasm. After exposure to HCY at the concentrations mentioned above, the expression of MIP-1? mRNA was significantly increased in a dose-dependent manner. Analysis of variance showed that there was significant difference between groups ( F= 606.38, P
8.Effect of lipid peroxidation on expression of vascular cell adhesion molecule-1 in cultured human endothelial cells
Feiyan ZOU ; Shuxiu WANG ; Xuewei ZHU ; Zhongdua DENG
Chinese Journal of Pathophysiology 1989;0(06):-
AIM: To observe the expression of vascular cell adhesion molecule-1 (VCAM-1) in cultured human umbilical vein endothelial cells (HUVEC) by lipid peroxidation injury induced by exposure to diamide. METHODS: Expression of VCAM-1 mRNA and protein in HUVEC was determined by in situ hybridization and a cell enzyme-linked immunosorbent essay (cell ELISA), respectively. RESULTS: The HPIAS-1000 image analytic system in situ hybridization detected that the mean absorbance values in experiment groups(1, 5 and 10 ?mol/L diamide for 8 hours) were 0.147?0.013, 0.292?0.020 and 0.396?0.022, which were 1.91-fold, 3.79-fold and 5.14-fold as much as that of the control group (0.077?0.011), respectively. There was significant statistical difference between groups ( P

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