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A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance
Sponsor: Jiangsu Cancer Institute & Hospital
Summary
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS/BRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS/BRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-06-15
Completion Date
2028-08-15
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Serplulimab+Fruquintinib+XELOX
combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. The dosing schedule is as follows: Fruquintinib: 3 mg/day, QD, PO, daily for 21 days of each 28-day cycle Serplulimab: 4.5 mg/kg, D1, intravenous infusion, Q3W XELOX :Oxaliplatin: 130 mg/m², intravenous infusion over 0-2 hours, D1, Q3W Capecitabine: 1000 mg/m², PO, BID, D1-14, Q3W Maintenance therapy administration: After completion of the combination therapy, subjects with a response assessment of CR, PR, or SD, , will enter the maintenance phase: Fruquintinib、Serplulimaband Capecitabine , until diseas progression, unacceptable toxicity, or voluntary withdrawal of informed consent
Locations (16)
Changzhou Tumor Hospital (Changzhou Fourth People's Hospital)
Changzhou, Jiangsu, China
Liyang People's Hospital
Changzhou, Jiangsu, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Huaian First People's Hospital
Huai'an, Jiangsu, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, China
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China
Nantong University Cancer Hospital
Nantong, Jiangsu, China
The First People's Hospital of Nantong
Nantong, Jiangsu, China
Changshu No.2 People's Hospital
Suzhou, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Wuxi Huishan District People's Hospital
Wuxi, Jiangsu, China
Jiangyin People's Hospital
Wuxi, Jiangsu, China
Xuzhou First People's Hospital
Xuzhou, Jiangsu, China
Yangzhou University Affiliated Jiangdu People's Hospital
Yangzhou, Jiangsu, China
Yizheng People's Hospital
Yangzhou, Jiangsu, China