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Radical Concurrent Chemoradiotherapy With DDP/5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 1, 2026 (before its estimated September 8, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Apr 20, 2026 to Sep 8, 2026
    • Study completion date: Feb 28, 2027 to Jun 8, 2029
    v4
  2. Study description expanded, about 4 wordsv3
  3. Primary completion date: Apr 20, 2024 to Apr 20, 2026
    • Primary endpoint revised
    • Start date changed from estimate of Apr 20, 2024 to Apr 12, 2024
    • Study title expanded, about 1 word
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are: Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs. Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY.
Trial Details
NCT Number NCT06364384
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Conditions
(from sponsor)		 Rectal Squamous Cell Carcinoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov