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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Investigator-assessed Progression-Free Survival(PFS) — From enrollment to the end of treatment at 18 months
The time from the start of treatment in cancer patients to the observation of disease progression or death from any cause
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Changzhou Tumor Hospital (Changzhou Fourth People's Hospital) | Changzhou | Jiangsu | |
| Liyang People's Hospital | Changzhou | Jiangsu | |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | |
| Huaian First People's Hospital | Huai'an | Jiangsu | |
| The First People's Hospital of Lianyungang | Lianyungang | Jiangsu | |
| First Affiliated Hospital of Nanjing Medical Unviersity | Nanjing | Jiangsu | |
| Jiangsu Cancer Institute & Hospital | Nanjing | Jiangsu | |
| Nantong University Cancer Hospital | Nantong | Jiangsu | |
| The First People's Hospital of Nantong | Nantong | Jiangsu | |
| Changshu No.2 People's Hospital | Suzhou | Jiangsu | |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | |
| Wuxi Huishan District People's Hospital | Wuxi | Jiangsu | |
| Jiangyin People's Hospital | Wuxi | Jiangsu | |
| Xuzhou First People's Hospital | Xuzhou | Jiangsu | |
| Yangzhou University Affiliated Jiangdu People's Hospital | Yangzhou | Jiangsu | |
| Yizheng People's Hospital | Yangzhou | Jiangsu |
More Jiangsu Cancer Institute & Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07622550 on ClinicalTrials.gov ↗ ← All trials in China