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RECRUITING
NCT06928584
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

221

Start Date

2025-03-10

Completion Date

2030-03-10

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China