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FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer
Sponsor: Ye Xu
Summary
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.
Official title: Exploratory Clinical Study of FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2026-03-01
Completion Date
2027-01-31
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Serplulimab
Serplulimab: 200 mg IV Day 1, q2w
Fruquintinib
Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
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
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Xuhui, China