Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Apr 2025 → Nov 1, 2026
See other at-risk trials from Sir Run Run Shaw Hospital

Record History

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  1. Notable Primary completion pushed from Apr 2025 to Nov 1, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 2 of 6 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  3. Minor 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.
Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer.In view of the shortcomings of the current preoperative neoadjuvant treatment model for locally advanced rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 2 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy.
Trial Details
NCT Number NCT05752136
Lead Sponsor Sir Run Run Shaw Hospital
Conditions
(from sponsor)
Rectal Cancer
Related terms Rectal Neoplasms
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov