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RECRUITING
NCT05628038
PHASE2

The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

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

Interventions

DRUG

PD-1 antibody

PD-1 antibody (Toripalimab): 240mg q3w or 160mg q2w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUG

5FU

400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)

DRUG

folinic acid

400 mg/m2 q2w

DRUG

Oxaliplatin

130 mg/m² q3w or 85 mg/m² q2w

DRUG

Irinotecan

180 mg/m² q2w and 200 mg/m² q3w

DRUG

Raltitrexed

2 mg/m² q2w and 3 mg/m² q3w

DRUG

Cetuximab

400 mg/m² q2w

DRUG

Bevacizumab

5 mg/kg q2w or 7.5mg/kg q3w

RADIATION

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