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Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Interventions modified
    • Start date: May 1, 2025 to May 6, 2025
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints: 8 to 7
  2. Phase: Phase 2 to Phase 2/3v3 Show 6 more changesShow less
    • Enrollment target: 134 to 430
    • 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: 9 to 8
    • Eligibility criteria expanded, about 2 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Most rectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) and respond poorly to PD-1 inhibitors. Radiotherapy can enhance tumor antigen release and improve responsiveness to PD-1 blockade in MSS/pMMR rectal cancer. Tumor-draining lymph nodes (TDLNs) are critical sites for anti-tumor immune activation, but radiation-induced damage and fibrosis may impair lymphatic drainage and immune responses. Previous studies have reported a remarkable pathologic complete response (pCR) rate of 77.8% using node-sparing radiotherapy in locally advanced rectal cancer. This study aims to evaluate whether node-sparing short-course radiotherapy followed by sequential chemotherapy and PD-1 blockade can improve complete response rate in the phase II part and event-free survival in phase III part, together with sphincter preservation, treatment tolerance, and prognosis in patients with mid-low pMMR/MSS rectal cancer.
Trial Details
NCT Number NCT06958432
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Conditions
(from sponsor)		 Rectal Cancer, Neoadjuvant Therapies, Immune Checkpoint Therapy, Radiotherapy
Related terms Rectal Neoplasms
Enrollment 430 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov