FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

Sponsor
Ye Xu
Study ID
NCT07446465
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Colorectal Cancer (Locally Advanced or Metastatic)
  • Colorectal Cancer Microsatellite Stable (MSS)

Eligibility Criteria

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

Interventions

  • Serplulimab — DRUG
    Serplulimab: 200 mg IV Day 1, q2w
  • Fruquintinib — DRUG
    Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks
  • mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) — DRUG
    Oxaliplatin 85 mg/m² IV q2w Leucovorin 400 mg/m² IV q2w 5-FU 400 mg/m² IV bolus Day 1 5-FU 1200 mg/m²/day continuous IV infusion Days 2-3

Study Details

To evaluate the efficacy and safety of immune checkpoint inhibitor-based combination therapy with targeted therapy and chemotherapy in patients with locally advanced unresectable or metastatic colorectal cancer.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

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

Arms

  • Experimental: Conversion Therapy
    Conversion Therapy (≤6 months) Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks mFOLFOX6: Oxaliplatin 85 mg/m² IV q2w Leucovorin 400 mg/m² IV q2w 5-FU 400 mg/m² IV bolus Day 1 5-FU 1200 mg/m²/day continuous IV infusion Days 2-3 Serplulimab: 200 mg IV Day 1, q2w Fruquintinib must be stopped ≥2 weeks prior to surgery and resumed ≥4 weeks postoperatively.

Primary Outcome Measure

Conversion Rate to Surgery [ Time Frame: ≤ 6 months ]

Central Contacts