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NOT YET RECRUITING
NCT07622550
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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