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Node-Sparing Short-Course Radiotherapy Plus Chemotherapy, Bevacizumab and PD-1 Inhibitor in Metastatic pMMR/MSS Colorectal Cancer (MODIFI-CRC)

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Phase: Phase 2 to Phase 2/3v3 Show 5 more changesShow less
    • Enrollment target: 100 to 286
    • Primary completion date: Dec 31, 2027 to Dec 31, 2030
    • Primary endpoints: 1 to 2
    • Study completion date: Dec 31, 2028 to Dec 31, 2031
    • Secondary endpoints revised (5)
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 current standard first-line treatment for metastatic colorectal cancer is chemotherapy combined with targeted therapy, yet the prognosis remains poor. Although combining immunotherapy, anti-angiogenic agents, and chemotherapy has shown some efficacy in MSS/pMMR metastatic patients, progression-free survival (PFS) remains suboptimal. Radiotherapy-particularly high-dose radiotherapy-can enhance tumor antigen release and potentially improve the response of MSS/pMMR colorectal cancer to PD-1 inhibitors. Tumor-draining lymph nodes (TDLNs) are key sites for PD-1-mediated anti-tumor activity, but radiation-induced damage and fibrosis may impair their immune function. Prior studies have reported a remarkable pathologic complete response (pCR) rate of 77.8% using node-sparing radiotherapy in locally advanced rectal cancer. This phase II/III study aims to evaluate whether node-sparing modified short-course radiotherapy combined with chemotherapy, bevacizumab, and PD-1 blockade can improve objective response rate (ORR) in phase II and progression-free survival (PFS) in phase III, together with treatment tolerance, and overall prognosis in patients with pMMR/MSS metastatic colorectal cancer.
Trial Details
NCT Number NCT06958419
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Conditions
(from sponsor)		 Immune Checkpoint Therapy, Radiotherapy, Metastatic Colorectal Cancer (CRC)
Related terms Colorectal Neoplasms
Enrollment 286 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov