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
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Metastatic Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Chemotherapy, Bevacizumab, Adebrelimab — DRUGAdebrelimab: 1200mg,q3w Bevacizumab: 7.5mg/kg,q3w Fruquintinib: 4mg po d1\~d14, q3w Chemotherapy: XELOX/mXELIRI: conventional dose
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 treatmentParticipants 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 treatmentParticipants 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 treatmentParticipants will recieve Fruquintinib (4mg po d1\~d14, q3w) combined with Adebrelimab (1200mg, q3w).
Primary Outcome Measure
Objective Response Rate [ Time Frame: 2 years ]
Related Studies
- Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic CancerPHASE2 · Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- A Study of ART0380 for the Treatment of Advanced or Metastatic Solid TumorsPHASE1/PHASE2 · Recruiting · Artios Pharma Ltd · Birmingham, Alabama
- A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)PHASE1 · Recruiting · Hoffmann-La Roche · Birmingham, Alabama
- Couple-Based Mindfulness Intervention for Metastatic Colorectal CancerRecruiting · University of Colorado, Denver · Aurora, Colorado