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The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer
Sponsor: Fudan University
Summary
The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy +/- target therapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment. Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.
Official title: Hypofractionated Radiotherapy Combined With Toripalimab and Chemotherapy +/- Target Therapy for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2022-11-30
Completion Date
2025-12-01
Last Updated
2024-10-01
Healthy Volunteers
No
Conditions
Interventions
PD-1 antibody
PD-1 antibody (Toripalimab): 240mg q3w or 160mg q2w
Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
5FU
400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)
folinic acid
400 mg/m2 q2w
Oxaliplatin
130 mg/m² q3w or 85 mg/m² q2w
Irinotecan
180 mg/m² q2w and 200 mg/m² q3w
Raltitrexed
2 mg/m² q2w and 3 mg/m² q3w
Cetuximab
400 mg/m² q2w
Bevacizumab
5 mg/kg q2w or 7.5mg/kg q3w
Radiation
25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence tumor. 35-60Gy/5-8Fx irradiation for distance metastasis tumor.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China