A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab

Sponsor
Fudan University
Study ID
NCT06513221
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a prospective, multi-arm, phase II clinical trial that uses transcriptome profiling to guide the evaluation of the efficacy of multiple lines of standard chemotherapy and bevacizumab combined with adebrelimab in patients with MSS-type metastatic colorectal cancer, aiming to expand the immunotherapy cohort while accurately narrowing the population of MSS-type colorectal cancer that benefits from immunity. This study includes a screening period, a treatment period, and a follow-up period.

Key Dates

First listed
Jul 22, 2024
Start date
Jul 25, 2024
Status verified
Jul 2024
Primary completion
Apr 1, 2026
Completion
Apr 12, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: First Line treatment
    Participants will recieve chemotherapy (XELOX: Oxaliplatin injection and capecitabine tablets) combined with Bevacizumab (7.5mg/kg, q3w) as well as Adebrelimab (1200mg, q3w).
  • Experimental: Second Line treatment
    Participants will recieve chemotherapy (mXELIRI: capecitabine tablets plus irinotecan injection) combined with Bevacizumab (7.5mg/kg, q3w) as well as Adebrelimab (1200mg, q3w).
  • Experimental: Third Line treatment
    Participants will recieve Fruquintinib (4mg po d1\~d14, q3w) combined with Adebrelimab (1200mg, q3w).

Primary Outcome Measure

Objective Response Rate [ Time Frame: 2 years ]

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