Node-sparing Short-Course Radiation Combined With CAPOX and Tislelizumab for MSS Rectal Cancer
NCT Number: NCT06507371
Acronym: mRCAT-III
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Rectal Cancer
Interventions: RADIATION: node-sparing modified short-course radiotherapy|DRUG: PD-1 antibody|DRUG: Capecitabine|DRUG: Oxaliplatin|RADIATION: standard short-course radiotherapy
Sponsor: Sir Run Run Shaw Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-08-15
Locations: Sir Run Run Shao hospital, Hanzhou, Zhejiang, 310016, China

Summary:
This is a randomized, prospective, multicenter, open-label, Phase III clinical trial to evaluate node-sparing modified short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with CAPOX and PD-1 Inhibitor (Tislelizumab) compared with standard short-course radiation combined with CAPOX for patients with MSS middle and low rectal cancer. A total of 170 patients will be enrolled in this trial. The primary endpoint is the rate of pathological complete response (pCR). The EFS rate, ORR, organ preservation rate, long-term prognosis, and adverse effects will also be analyzed.

Primary Outcome Measures: pathological complete response (pCR) rate, Pathological complete response (pCR) rate, within 10 days after completion of surgery
Secondary Outcome Measures: event free survival (EFS), the time from randomization until relapse or progression, 3 years after randomization|overall response rate (ORR), The ORR represents the proportion of patients whose tumor burden decreases by a pre-defined clinically meaningful threshold and is maintained for a minimum required duration, which included complete response (CR) rate and partial response (PR) rate, within 10 days after completion of chemotherapy|organ preservation rate, patients who are able to retain their rectum/anal sphincter after treatment, without requiring a permanent colostomy., within 10 days after completion of chemotherapy|Disease free survival(DFS), The three-year disease-free survival of patients., 3 years after chemotherapy or surgery|Overall survival(OS）, The three-year overall survival of patients., 3 years after chemotherapy or surgery|Adverse effects rate, Rate of radiotherapy, chemotherapy and immunotherapy related adverse events, From date of initiation of treatment until the date of death from any cause, assessed up to 5 years|Rectal specific quality of life assessment via QLQ-CR29 Rectal specific quality of life assessment via QLQ-CR29 Rectal specific quality of life assessment via QLQ-CR29, Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life., Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery|Quality of life assessment via QLQ-C30, Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life, Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery|Validation of the Wexner score, The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence., Baseline and months 3, 6, 12, 24, 36, 60 after the chemotherapy or surgery