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

Study acronym: TORCH-R
StatusUnknown
PhasePhase 2
Started

Record status This record was last updated October 1, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Start date: Aug 18, 2022 to Nov 30, 2022
    • Interventions: 5FU (Drug), Capecitabine (Drug), Irinotecan (Drug), Oxaliplatin (Drug), PD-1 antibody (Drug), Radiation (Radiation), Raltitrexed (Drug)… to 5FU (Drug), Bevacizumab (Drug), Capecitabine (Drug), Cetuximab (Drug), Irinotecan (Drug), Oxaliplatin (Drug), PD-1 antibody (Drug)…
    v4
  3. Primary endpoint revisedv3 Show 4 more changesShow less
    • Interventions: Capecitabine (Drug), Fluorouracil (Drug), Irinotecan (Drug), Oxaliplatin (Drug), PD-1 antibody (Drug), Radiation (Radiation), Raltitrexed… to 5FU (Drug), Capecitabine (Drug), Irinotecan (Drug), Oxaliplatin (Drug), PD-1 antibody (Drug), Radiation (Radiation), Raltitrexed (Drug)…
    • Eligibility criteria shortened, about 9 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 71 words
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 75 to 93
    • Start date changed from estimate of Dec 1, 2022 to Aug 18, 2022
    • Interventions: Capecitabine (Drug), Oxaliplatin (Drug), PD-1 antibody (Drug), Radiotherapy (Radiation) to Capecitabine (Drug), Fluorouracil (Drug), Irinotecan (Drug), Oxaliplatin (Drug), PD-1 antibody (Drug), Radiation (Radiation), Raltitrexed…
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 4 to 6
    • Site details revised
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05628038
Lead Sponsor Fudan University
Conditions
(from sponsor)		 Recurrent Rectal Cancer
Related terms Rectal Neoplasms
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov