NCT05628038

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

Hypofractionated Radiotherapy Combined With Toripalimab and Chemotherapy +/- Target Therapy for Locally Recurrent Rectal Cancer: a Single-arm, Two-cohort, Phase II Trial (TORCH-R)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For patients with locally recurrent rectal cancer (LRRC), response rate of chemoradiotherapy is 40-50% and only approximately 40-50% of patients with recurrent rectal cancer can undergo R0 resection. Recent studies have shown promising synergistic effects of the combination of immunotherapy (PD-1/PD-L1 antibodies) and neoadjuvant chemoradiotherapy (nCRT) in locally advanced rectal cancer (LARC). Thus, for LRRC patients, addition of immunotherapy to CRT is likely to further improve the response rate and prognosis.

Conditions

• Recurrent Rectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-30
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-11-28
• Last updated: 2024-10-01

Locations

1 site across 1 country: China