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.Association between mental health status and post-ablation recurrence in elderly atrial fibrillation patients
Zhaoxu JIA ; Cong YUAN ; Chao JIANG ; Xin DU ; Jianzeng DONG ; Changsheng MA
Chinese Journal of Arteriosclerosis 2024;32(12):1057-1061
Aim To explore the association between mental health status and post-ablation recurrence in elderly atrial fibrillation patients.Methods Consecutive patients aged≥60 years who underwent catheter ablation for atrial fi-brillation in Beijing Anzhen Hospital were enrolled,baseline clinical characteristics,comorbidities and treatment were col-lected.Five item mental health inventory(MHI-5)was used to evaluate the mental health status,and 76 points were taken as the cut-off value.Each patient was followed up at 3,6 and 12 months after ablation to assess atrial fibrillation recurrence,mental health status and other adverse events.Multivariate Logistic regression analysis was conducted to ex-amine the association between mental health status and the risk of atrial fibrillation recurrence.Results A total of 238 elderly patients with atrial fibrillation were enrolled,including 58 patients in the MHI-5≤76 points group and 180 patients in the MHI-5>76 points group.During 12 months follow-up,73 patients(30.7%)developed atrial fibrillation recur-rence,and the recurrence rate in the MHI-5≤76 points group was significantly higher than that in the MHI-5>76 points group[58.6%(34/58)vs.21.7%(39/180),P<0.001].Multivariate Logistic analysis showed that after adjusting for demographic data and clinical factors,MHI-5≤76 points was significantly associated with a higher risk of atrial fibrillation recurrence after catheter ablation(OR=6.13,95%CI:3.08~12.24,P<0.001).Conclusion Poor mental health status is significantly associated with higher post-ablation recurrence in elderly atrial fibrillation patients.
4.Association between mental health status and post-ablation recurrence in elderly atrial fibrillation patients
Zhaoxu JIA ; Cong YUAN ; Chao JIANG ; Xin DU ; Jianzeng DONG ; Changsheng MA
Chinese Journal of Arteriosclerosis 2024;32(12):1057-1061
Aim To explore the association between mental health status and post-ablation recurrence in elderly atrial fibrillation patients.Methods Consecutive patients aged≥60 years who underwent catheter ablation for atrial fi-brillation in Beijing Anzhen Hospital were enrolled,baseline clinical characteristics,comorbidities and treatment were col-lected.Five item mental health inventory(MHI-5)was used to evaluate the mental health status,and 76 points were taken as the cut-off value.Each patient was followed up at 3,6 and 12 months after ablation to assess atrial fibrillation recurrence,mental health status and other adverse events.Multivariate Logistic regression analysis was conducted to ex-amine the association between mental health status and the risk of atrial fibrillation recurrence.Results A total of 238 elderly patients with atrial fibrillation were enrolled,including 58 patients in the MHI-5≤76 points group and 180 patients in the MHI-5>76 points group.During 12 months follow-up,73 patients(30.7%)developed atrial fibrillation recur-rence,and the recurrence rate in the MHI-5≤76 points group was significantly higher than that in the MHI-5>76 points group[58.6%(34/58)vs.21.7%(39/180),P<0.001].Multivariate Logistic analysis showed that after adjusting for demographic data and clinical factors,MHI-5≤76 points was significantly associated with a higher risk of atrial fibrillation recurrence after catheter ablation(OR=6.13,95%CI:3.08~12.24,P<0.001).Conclusion Poor mental health status is significantly associated with higher post-ablation recurrence in elderly atrial fibrillation patients.
5.The safety and prognosis of radical surgery in old patients of colorectal cancer
Meng WANG ; Yujuan JIANG ; Sicheng ZHOU ; Jianwei LIANG ; Zhaoxu ZHENG
Chinese Journal of General Surgery 2022;37(6):425-429
Objective:To evaluate the safety and feasibility of radical surgery and explore prognostic factors affecting cancer-specific survival (CSS) in elderly patients with colorectal cancer (CRC).Methods:From Jan 2010 to Dec 2020, a total of 372 elderly (aged over 80 years) CRC patients who underwent curative resection at the National Cancer Center were enrolled. Preoperative clinical features, perioperative outcomes and postoperative pathological characteristics were collected.Results:In the multivariable COX regression analysis, BMI ≥30 kg/m 2 ( HR:2.30, 95% CI: 1.27-4.17, P=0.006) and N1-N2 stage ( HR: 2.97,95% CI:1.48-5.97, P=0.002) correlated with worse CCS. Conclusions:The results of this study demonstrated that radical resection for CRC is safe and feasible for patients over 80 years of age. BMI and N stage were independent prognostic factors for elderly CRC patients after radical resection.
6.Analysis of influencing factors for hepatic artery complications of liver transplantation from donation after citizen's death
Yang CAO ; Hongtao ZHANG ; Wei PENG ; Jianlin WANG ; Zijian JIANG ; Kaishan TAO ; Zhaoxu YANG
Chinese Journal of Digestive Surgery 2021;20(10):1055-1060
Objective:To investigate the influencing factors for hepatic artery complica-tions of liver transplantation from donation after citizen's death.Methods:The retrospective cohort study was conducted. The clinicopathological data of 147 recipients who underwent liver transplan-tation from donation after citizen's death in Xijing Hospital of Air Force Military Medical University from January 2015 to June 2020 were collected. There were 109 males and 38 females, aged (46±12)years. All recipients underwent liver transplantation from donation after citizen's death. Observation indicators: (1) surgical situations; (2) occurrence of hepatic artery complications after liver transplantation; (3) analysis of donor related influencing factors for hepatic artery complications after liver transplantation; (4) analysis of recipient related influencing factors for hepatic artery complications after liver transplantation; (5) follow-up. Follow-up was conducted using outpatient examination or telephone interview to detect survival of recipients up to June 2021. Measurement data with normal distribution were represented as Mean± SD. Measurement data with skewed distribution were represented as M(range). Univariate analysis was conducted using the Fisher exact probability, and multivariate analysis was conducted using the COX regression model. Kaplan-Meier method was used to calculate the cumulative survival rate and draw the survival curve. Results:(1) Surgical situations: of the 147 recipients, 108 cases underwent orthotopic liver transplantation, and 39 cases underwent piggyback liver transplantation. The operation time of 147 recipients was (458±101)minutes. (2) Occurrence of hepatic artery complications after liver transplantation: 4 of the 147 recipients had hepatic artery complications, including 3 cases with hepatic artery embolism and 1 case with hepatic artery stenosis. The time to occurrence of hepatic artery complications after liver transplantation was (5±2)days. (3) Analysis of donor related influencing factors for hepatic artery complications after liver transplantation: results of univariate analysis showed that age, atherosclerosis, fatty liver and arterial variation were not donor related factors influencing hepatic artery complications after liver transplantation ( P>0.05). (4) Analysis of recipient related influencing factors for hepatic artery complications after liver transplantation: results of multivariate analysis showed that insufficient hepatic artery blood flow in the recipient was an independent risk factor for hepatic artery complications after liver transplantation ( hazard ratio=10.13, 95% confidence interval as 1.05-97.42, P<0.05). (5) Follow-up: 146 of the 147 recipients were followed up for 1 to 77 months, with a median follow-up time of 34 months. The 1-year cumulative survival rate of the 146 recipients was 92.2%. Conclusion:Insufficient hepatic artery blood flow of the recipient is an independent risk factor for hepatic artery complications after liver transplantation from donation after citizen's death.
7.Analysis of risk factors of severe postoperative complications in elderly patients with colorectal cancer aged over 80 years
Wei PEI ; Sicheng ZHOU ; Jianwei LIANG ; Zhaoxu ZHENG ; Zheng WANG ; Zheng LIU ; Zheng JIANG ; Qian LIU ; Zhixiang ZHOU ; Xishan WANG
Chinese Journal of Gastrointestinal Surgery 2020;23(7):695-700
Objective:To investigate the risk factors of severe postoperative complications in elderly patients with colorectal cancer aged over 80 years old.Methods:A retrospective case-control study was conducted to collect and analyze the clinicopathological data of patients (≥80 years old) who underwent radical colorectal cancer surgery at department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from January 2010 to December 2018. A total of 269 patients were included in the study, including 160 males and 109 females. The average age was 83 (80-94) years. Among them, the pathological TNM stage was 16 in stage I, 76 in stage II, 167 in stage III, and 10 in stage IV. According to Clavien-Dindo classification, the postoperative complications of grade III and above were defined as serious complications. To analyze the relationship between the patient's clinical data, such as general information, the surgeon's experience (whether to complete more than 500 radical colorectal cancer surgery), intraoperative conditions and the occurrence of severe complications. Univariate analysis was conducted with the chi-squared test. Multivariate logistic regression analysis was used for statistically significant variables in univariate analysis.Results:Of the 269 patients, 34 (12.6%) had severe complications after surgery. The incidence of postoperative complications ranged from high to low, respectively, for pulmonary infection (8/269,3.0%), intestinal obstruction (8/269, 3.0%) and anastomotic leakage (7/269, 2.6%). One patient died of pulmonary embolism and one patient died of multiple organ failure, with a perioperative mortality rate of 0.7% (2/269). On univariate analysis, the occurrence of severe postoperative complications was associated with age (χ 2=8.181, P=0.004), American society of anesthesiologists grade (χ 2=7.945, P=0.005), preoperative albumin level (χ 2=9.088, P=0.003), operation experience (χ 2=9.395, P=0.002). Multivariable logistic regression analysis showed that age ≥85 years old (OR=4.415, 95% CI: 1.702-11.453, P=0.080), preoperative albumin <35 g/L (OR=2.544, 95%CI: 1.083-5.974, P=0.032), and less-experieced group (OR=2.475, 95% CI:1.082-5.661, P=0.032) was independent risk factor for severe postoperative complications. The incidence of serious postoperative complications was similar in patients undergoing laparoscopy and laparotomy [10.1% (17/169) vs. 17.0% (17/100), χ 2=2.741, P=0.098]. Conclusion:Adequate preoperative evaluation, appropriate perioperative nutritional support and experienced specialists are the key factors to ensure the successful perioperative period of elderly patients with colorectal cancer aged over 80 years old. In addition, more attention should be paid to the elderly patients aged ≥85 years.
8.Analysis of risk factors of severe postoperative complications in elderly patients with colorectal cancer aged over 80 years
Wei PEI ; Sicheng ZHOU ; Jianwei LIANG ; Zhaoxu ZHENG ; Zheng WANG ; Zheng LIU ; Zheng JIANG ; Qian LIU ; Zhixiang ZHOU ; Xishan WANG
Chinese Journal of Gastrointestinal Surgery 2020;23(7):695-700
Objective:To investigate the risk factors of severe postoperative complications in elderly patients with colorectal cancer aged over 80 years old.Methods:A retrospective case-control study was conducted to collect and analyze the clinicopathological data of patients (≥80 years old) who underwent radical colorectal cancer surgery at department of Colorectal Surgery, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from January 2010 to December 2018. A total of 269 patients were included in the study, including 160 males and 109 females. The average age was 83 (80-94) years. Among them, the pathological TNM stage was 16 in stage I, 76 in stage II, 167 in stage III, and 10 in stage IV. According to Clavien-Dindo classification, the postoperative complications of grade III and above were defined as serious complications. To analyze the relationship between the patient's clinical data, such as general information, the surgeon's experience (whether to complete more than 500 radical colorectal cancer surgery), intraoperative conditions and the occurrence of severe complications. Univariate analysis was conducted with the chi-squared test. Multivariate logistic regression analysis was used for statistically significant variables in univariate analysis.Results:Of the 269 patients, 34 (12.6%) had severe complications after surgery. The incidence of postoperative complications ranged from high to low, respectively, for pulmonary infection (8/269,3.0%), intestinal obstruction (8/269, 3.0%) and anastomotic leakage (7/269, 2.6%). One patient died of pulmonary embolism and one patient died of multiple organ failure, with a perioperative mortality rate of 0.7% (2/269). On univariate analysis, the occurrence of severe postoperative complications was associated with age (χ 2=8.181, P=0.004), American society of anesthesiologists grade (χ 2=7.945, P=0.005), preoperative albumin level (χ 2=9.088, P=0.003), operation experience (χ 2=9.395, P=0.002). Multivariable logistic regression analysis showed that age ≥85 years old (OR=4.415, 95% CI: 1.702-11.453, P=0.080), preoperative albumin <35 g/L (OR=2.544, 95%CI: 1.083-5.974, P=0.032), and less-experieced group (OR=2.475, 95% CI:1.082-5.661, P=0.032) was independent risk factor for severe postoperative complications. The incidence of serious postoperative complications was similar in patients undergoing laparoscopy and laparotomy [10.1% (17/169) vs. 17.0% (17/100), χ 2=2.741, P=0.098]. Conclusion:Adequate preoperative evaluation, appropriate perioperative nutritional support and experienced specialists are the key factors to ensure the successful perioperative period of elderly patients with colorectal cancer aged over 80 years old. In addition, more attention should be paid to the elderly patients aged ≥85 years.
9. Association between weight control and recurrence of atrial fibrillation after catheter ablation in overweight and obese patients
Zhaoxu JIA ; Chao JIANG ; Shangxin LU ; Jiapeng LIU ; Xueyuan GUO ; Songnan LI ; Nian LIU ; Chenxi JIANG ; Caihua SANG ; Ribo TANG ; Deyong LONG ; Ronghui YU ; Rong BAI ; Jiahui WU ; Xin DU ; Jianzeng DONG ; Changsheng MA
Chinese Journal of Cardiology 2019;47(8):595-601
Objectives:
This study explored the relationship between weight control and atrial fibrillation (AF) recurrence after catheter ablation in overweight and obese patients.
Methods:
We prospectively enrolled consecutive 333 overweight and obese patients aged 28 to 87 years old, who underwent catheter ablation for AF in Beijing Anzhen Hospital between October 2015 and February 2016. Data of patients′ characteristics, laboratory examination and treatment were collected at baseline. Each patient was followed up at 3, 6 and 12 months after ablation to collect information on weight, AF recurrence, stroke, major bleeding, hospitalization for cardiovascular reasons and death, etc. Patients were divided into weight controlled group (ΔBMI<-1 kg/m2) and weight uncontrolled group (ΔBMI≥-1 kg/m2), according to the changes in the most recent exposure BMI before AF recurrence in patients with recurrence or the BMI at 12 months′ follow-up in patients without recurrence and the BMI at baseline. Multivariate logistic regression was performed to adjust other known risk factors of AF recurrence and to explore the association between weight control and AF recurrence after catheter ablation.
Results:
There were 54 patients in weight controlled group and 279 patients in weight uncontrolled group. There were no significant differences in age, gender, education level, left atrial size and history of hypertension between the two groups (all
10.Short-term outcomes of patients treated with enhanced recovery after surgery combined with laparoscopic colorectal cancer surgery
Pu CHENG ; Zhao LU ; Mingguang ZHANG ; Xu GUAN ; Haitao ZHOU ; Jianwei LIANG ; Wei PEI ; Zheng LIU ; Zheng JIANG ; Qian LIU ; Xishan WANG ; Zhaoxu ZHENG
Chinese Journal of General Surgery 2019;34(3):204-207
Objective To investigate the safety and efficacy of enhanced recovery after surgery (ERAS) used in laparoscopic colorectal cancer surgery.Methods We conducted a retrospective analysis of the medical records of 99 cases treated with ERAS programed laparoscopic colorectal cancer surgery (ERAS group) and 103 cases treated with traditional perioperative care and laparoscopic colorectal cancer surgery (controlled group) from Mar 2017 to Sep 2017 in our center.Results There was no significant difference in age,gender,BMI,ASA classification,tumor location,operation time,pathological stage and the incidence of postoperative complications between ERAS group and controlled group (all P > 0.05).Compared to control group,ERAS had less blood loss,shorter time to pass first flatus,stool and start diet and shorter hospitalization day,with all the difference statistically significant [(60 ± 63)ml vs.(112 ± 245)ml,(3.0±0.8)dvs.(4.3 ±1.2)d,(3.5 ±1.0)dvs.(4.6±1.3)d,(4.1 ±1.2)dvs.(5.4± 2.0)d,(5.8±2.1)dvs.(7.8±2.5)d,t=-2.021、-9.216、-6.887、-5.252、-6.163,allP< 0.05].No patients in both groups suffered from readmission or death within 30 days after surgery.Conclusion Patients treated with ERAS programed laparoscopic colorectal cancer surgery is safe and effective,with rapid recovery and reduced hospital stay.

Result Analysis
Print
Save
E-mail