Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies）

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07007767
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • sintilimab — DRUG
    Sintilimab (anti-PD-1 monoclonal antibody) Specification: 100 mg/10 mL (10 mg/mL concentrated solution) Administration: Dose: 200 mg (fixed dose) Route: Intravenous (IV) infusion over 30-60 minutes Schedule: Day 1 of each 21-day cycle (Q3W)
  • Bevacizumab Biosimilar — DRUG
    Bevacizumab biosimilar (anti-VEGF monoclonal antibody) Specification: 100 mg/4 mL (25 mg/mL concentrated solution) Administration: Dose: 7.5 mg/kg (body weight-adjusted) Route: IV infusion Schedule: Day 1 of each 21-day cycle (Q3W)
  • Decitabine — DRUG
    Decitabine (hypomethylating agent) Specification: 10 mg lyophilized powder per vial Administration: Dose: 10 mg/m²/day (body surface area-adjusted) Route: IV infusion over 1 hour Schedule: Days 1-5 of each 21-day cycle (Q3W)

Study Details

This study investigates the efficacy and safety of sintilimab in combination with bevacizumab and decitabine for patients with advanced proficient mismatch repair/microsatellite stable (pMMR/MSS) colorectal cancer who have undergone ≥3 prior lines of systemic therapy. Participants will receive intravenous infusions of sintilimab, bevacizumab, and decitabine in 3-week treatment cycles until disease progression, intolerable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, loss to follow-up, death, or investigator-determined discontinuation criteria (whichever occurs first). The maximum treatment duration for sintilimab is 24 months.

Key Dates

First listed
Jun 6, 2025
Start date
Jun 15, 2025
Status verified
Jun 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sintilimab+bevacizumab+decitabine
    Subjects will receive Sintilimab (anti-PD-1 monoclonal antibody) in combination with Bevacizumab biosimilar（anti-VEGF monoclonal antibody) and Decitabine (hypomethylating agent) via intravenous infusion on a 3-week cycle (Q3W) until disease progression (PD), unacceptable toxicity, initiation of new antitumor therapy, withdrawal of informed consent, loss to follow-up, death, or investigator-determined discontinuation criteria (whichever occurs first). The maximum treatment duration for Sintilimab is 24 months.

Primary Outcome Measure

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator Assessment [ Time Frame: every 12 weeks (±7 days) up to 2 years ]

Central Contacts

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