FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02)

Study acronym: TORCH-PM02
StatusRecruiting
PhasePhase 3
Started

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Record History

  1. Recruitment opened
    • Start date pushed from Sep 1, 2026 to Oct 1, 2026
    • Site details revised
  2. 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.
The goal of this clinical trial is to test whether adding targeted radiation plus cadonilimab immunotherapy to standard second-line chemo works better for adults with colorectal cancer only spread to the peritoneum, and check how safe this combined treatment is. Its main research questions are: Does the combined treatment slow cancer growth for a longer time than standard chemo alone? What side effects will participants get from the new combination therapy? Researchers will compare the chemo-radiation-immunotherapy combination against standard chemo alone to see if the new plan shrinks tumors and improves outcomes. Participants will: Receive either the new combined treatment or standard chemo chosen randomly by chance Visit the hospital regularly for drug infusions, scans and physical exams Complete questionnaires about daily quality of life and report any discomfort
Trial Details
NCT Number NCT07815834
Lead Sponsor Fudan University
Conditions
(from sponsor)		 Colon Rectal Cancer Adenocarcinoma, Peritoneal (Metastatic) Cancer, Second-line Treatment, Radiation Therapy, Immunotherapy
Related terms Neoplasm Metastasis, Neoplasms
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov