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

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

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

Sponsors & Collaborators

• Fudan University

  lead OTHER

Principal Investigators

• Zhen Zhang, MD PhD, PhD · Fudan University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-10

Primary Completion

2030-03-10

Completion

2030-03-10

Countries

• China

Study Locations