Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated February 1, 2023 (before its estimated October 18, 2026 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 Jan 2023); last known: Active, Not Recruiting
  2. Phase: Phase 2/3 to Phase 2v3 Show 6 more changesShow less
    • Primary completion date: Oct 18, 2021 to Oct 18, 2026
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Start date: Oct 18, 2019 to Oct 28, 2019
    • Secondary endpoints: 5 to 6
    • Site details revised
  3. Eligibility criteria shortened, about 10 wordsv2
  4. 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.
In this study, participants with locally advanced rectal cancer patients will be treated according to MMR/MSI status. There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, dMMR or MSI-H patients will receive 4 cycles of neoadjuvant Pd1 antibody Sintilimab,followed by one of the following treatments: (1) surgery and adjuvant treatment, (2）another 4 cycles of sintilimab, followed by radical surgery or observation (only for cCR) . For Cohort B, pMMR/MSS/MSI-L patients will be randomized to receive neoadjuvant chemoradiotherapy ± four cycles of Pd1 antibody Sintilimab，followed by one of the following treatments: (1) curative surgery and four cycles of adjuvant chemotherapy;(2)four cycles of chemotherapy then observation (only cCR after neoadjuvant therapy)
Trial Details
NCT Number NCT04304209
Lead Sponsor Sun Yat-sen University
Conditions
(from sponsor)		 Colorectal Cancer Stage II, Colorectal Cancer Stage III
Related terms Colorectal Neoplasms
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov