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

Sponsor
Fudan University
Study ID
NCT06928584
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Recurrent Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Conventional Radiotherapy — RADIATION
    50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation (previous pelvic radiation)
  • Capecitabine — DRUG
    1000mg/m2 d1-14 q3w
  • 5-fluorouracil — DRUG
    400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)
  • folinic acid — DRUG
    400 mg/m2 q2w
  • Oxaliplatin — DRUG
    130 mg/m² q3w or 85 mg/m² q2w
  • Irinotecan — DRUG
    180 mg/m² q2w and 200 mg/m² q3w
  • Cetuximab — DRUG
    500 mg/m² q2w
  • Bevacizumab — DRUG
    5 mg/kg q2w or 7.5mg/kg q3w
  • Hypofractionated radiotherapy — RADIATION
    25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (previous pelvic radiation)
  • PD-1 antibody — DRUG
    200mg IV q3w

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
Apr 2025
Primary completion
Mar 10, 2030
Completion
Mar 10, 2030

Study Design

Enrollment
221 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Conventional radiotherapy arm
    Conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and investigator's choice of first-line chemotherapy +/- target therapy.
  • Experimental: Hypofractionated radiotherapy plus Immunotherapy arm
    Hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy.

Primary Outcome Measure

Progression-Free Survival [ Time Frame: up to 3 years ]

Central Contacts