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Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 10, 2024 (before its estimated March 1, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Study description expanded, about 3 wordsv10
  2. Collaborators: 7 to 8v9
  3. Enrollment target: 180 to 186
    • Study description shortened, about 49 words
    v8
  4. Secondary endpoints: 17 to 21v7
  5. Eligibility criteria expanded, about 25 words
    • Site details revised at 4 of 8 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Secondary endpoints: 16 to 17v5
  2. Enrollment target: 174 to 180v4
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 8 more changesShow less
    • Enrollment target: 120 to 174
    • Study sites: 0 to 8
    • Study completion date: Sep 1, 2024 to Sep 1, 2029
    • Interventions: Radiation therapy, chemotherapy and immune checkpoint inhibitor (Combination Product) to Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor) (Combination Product)
    • Study description expanded, about 224 words
    • Collaborators: 6 to 7
    • Publications: 3 to 4
    • Study title shortened, about 10 words
  4. Phase: Phase 2/3 to Phase 2v2 Show 7 more changesShow less
    • Start date: Mar 1, 2022 to Apr 1, 2022
    • Primary endpoints: 6 to 1
    • Enrollment target: 111 to 120
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 11 to 16
    • Collaborators: 7 to 6
    • Study title expanded, about 6 words
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+concurrent PD-1 inhibitor; Experiment group 2: chemoradiation+sequential PD-1 inhibitor) with a control group (chemoradiation only).
Trial Details
NCT Number NCT05245474
Lead Sponsor Beijing Friendship Hospital
Collaborators: Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing, Beijing Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, BeiGene
Conditions
(from sponsor)		 Locally Advanced Rectal Cancer
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov