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

Sponsor
Fudan University
Study ID
NCT05628038
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Rectal Cancer

Eligibility Criteria

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

Interventions

  • PD-1 antibody — DRUG
    PD-1 antibody (Toripalimab): 240mg q3w or 160mg q2w
  • Capecitabine — DRUG
    Capecitabine: 1000mg/m2 d1-14 q3w
  • 5FU — 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
  • Raltitrexed — DRUG
    2 mg/m² q2w and 3 mg/m² q3w
  • Cetuximab — DRUG
    400 mg/m² q2w
  • Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 30, 2022
Status verified
Sep 2024
Primary completion
Dec 1, 2024
Completion
Dec 1, 2025

Study Design

Enrollment
93 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    The enrolled patients will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence. Cohort A patients will receive CAPOX, FOLFIRI or mFOLFOX6 chemotherapy andcohort B patients will receive CAPOX, FOLFIRI, mFOLFOX6, mXELIRI, irinotecan and raltitrexed, or oxaliplatin and raltitrexed chemotherapy, based on previous chemotherapy and adverse reactions to chemotherapy agents or at the discretion of the oncologist. All metastasis sites will receive stereotactic ablative radiotherapy (SABR) between chemoimmunotherapy cycles. Five-fraction regimens (25-50Gy/5Fx) are delivered daily. Dose Constraints are based on SABR-COMET 10 trial. Besides, according to the medical oncologist recommendation, patients with unresectable pelvic recurrence or distant metastasis will receive target therapy based on the KRAS/NRAS/BRAF mutation station.

Primary Outcome Measure

Local objective response rate [ Time Frame: up to 1 year ]

Central Contacts