Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for Metastatic Colorectal Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06858969
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment group — DRUG
    Chidamide+XELOX + Bevacizumab+PD-1
  • Standard-of-care control group — DRUG
    XELOX + Bevacizumab+PD-1

Study Details

This phase II, open-label, dose-escalation study aims to (1) assess the safety and tolerability of chidamide in combination with PD-1 inhibitor, bevacizumab, and XELOX as first-line therapy for treatment-naïve metastatic colorectal cancer patients, (2) establish the recommended phase II dose (RP2D) of the combination regimen, and (3) obtain preliminary efficacy data including objective response rate (ORR) and progression-free survival (PFS).

Key Dates

First listed
Mar 5, 2025
Start date
Apr 9, 2025
Status verified
Feb 2025
Primary completion
Jan 8, 2026
Completion
Jan 8, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    PD-1 inhibitor: Dose determined per the manufacturer's instructions or investigator's discretion based on patient status. Bevacizumab: 7.5 mg/kg via intravenous infusion every 3 weeks (Q3W). XELOX regimen: Oxaliplatin: 130 mg/m² via intravenous infusion on Day 1; Capecitabine: 1000 mg/m² orally twice daily on Days 1-14; Repeated every 3 weeks for 6 cycles. Maintenance therapy after 6 cycles (experimental group): Chidamide: Administered at the maximum tolerated dose/recommended phase II dose (MTD/RP2D), orally twice weekly (on Days 1, 4, 8, 11, 15, and 18 of each cycle), 30 minutes after meals. PD-1 inhibitor, Bevacizumab, and Capecitabine: Continued at the same doses and schedules as during the initial treatment phase.
  • Active Comparator: Standard-of-care control group
    XELOX + Bevacizumab: Doses identical to the experimental group (Oxaliplatin 130 mg/m², Capecitabine 1000 mg/m², Bevacizumab 7.5 mg/kg Q3W) for 6 cycles. Maintenance therapy after 6 cycles: Bevacizumab (7.5 mg/kg Q3W) and Capecitabine (1000 mg/m² orally twice daily on Days 1-14 of each cycle).

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 24 months ]

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