NCT06928584

Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer

Multicenter, Randomized, Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Plus Immunotherapy and First-line Therapy Versus Conventional Radiotherapy Plus First-line Therapy in pMMR Locally Recurrent Rectal Cancer (TORCH-R2)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

TORCH-R2 is a prospective, multicenter, randomized, phase II clinical trial. Patients aged 18 years or older with pelvic recurrence rectal cancer without synchronous distant metastases or recent chemo- and/or radiotherapy treatment, Eastern Cooperative Oncology Group performance status of 0-1will be enrolled . Patients will be randomized to receive either hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy (experimental arm), or conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and chemotherapy +/- target therapy (control arm). Patiens will be restaged and followed by multidisciplinary team (MDT) for decision: radical surgery, sustained systerm+/- local treatment of non resection. The primary endpoint was progression-free survival. Secondary endpoints were objective response rate (ORR), complete response rate, R0 resection rate, duration of response (DOR), overall survival (OS), and safety and tolerability of the treatment.

Conditions

• Locally Recurrent Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Conventional Radiotherapy	50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation (previous pelvic radiation)
DRUG	Capecitabine	1000mg/m2 d1-14 q3w
DRUG	5-fluorouracil	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	Cetuximab	500 mg/m² q2w
DRUG	Bevacizumab	5 mg/kg q2w or 7.5mg/kg q3w
RADIATION	Hypofractionated radiotherapy	25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (previous pelvic radiation)
DRUG	PD-1 antibody	200mg IV q3w

Timeline

• Start date: 2025-03-10
• Primary completion: 2030-03-10
• Completion: 2030-03-10
• First posted: 2025-04-15
• Last updated: 2025-04-15

Locations

1 site across 1 country: China