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
1 other identifier
interventional
80
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2026
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2026
CompletedFirst Posted
Study publicly available on registry
June 3, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2028
June 3, 2026
May 1, 2026
1.5 years
May 28, 2026
May 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigator-assessed Progression-Free Survival（PFS）
The time from the start of treatment in cancer patients to the observation of disease progression or death from any cause
From enrollment to the end of treatment at 18 months
Secondary Outcomes (4)
Investigator-assessed Objective Response Rate（ORR）
From enrollment to the end of treatment at 18 months
Overall Survival（OS）
From enrollment to the end of treatment at 36 months
DCR
From enrollment to the end of treatment at 24 months
AEs
Through study completion, an average of 30 weeks
Study Arms (1)
Fruquintinib Combined With Serplulimab and XELOX
EXPERIMENTALThis study consists of two phases: combination and maintenance therapy. combination therapy administration： After screening and enrollment, patients will receive a first-line combination regimen of fruquintinib, serplulimab, and XELOX for 6-8 cycles. 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 NOTE: If lesions become resectable, surgical treatment should be performed.
Interventions
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
Eligibility Criteria
You may qualify if:
- to 75 years (inclusive), male or female.
- Diagnosis of advanced unresectable or metastatic colorectal cancer.
- Confirmed RAS/BRAF mutation by testing.
- No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)
- ECOG 0 - 1.
- Adequate major organ and bone marrow function (without any blood component or cell growth factor support within 14 days before enrollment):
- Hematology: absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥90 g/L.
- International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.
- Liver function: total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases).
- Renal function: serum creatinine ≤1.5 × ULN, and creatinine clearance (CCr) ≥50 mL/min.
- Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before treatment. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the study and for at least 6 months after the last dose
You may not qualify if:
- \- History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.
- Untreated central nervous system (CNS) metastases.
- Major surgery or severe trauma within 4 weeks prior to first study drug administration.
- Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment.
- Presence of any active autoimmune disease or history of autoimmune disease.
- History of other malignancies within the past 5 years, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Known inherited or acquired bleeding/thrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or currently receiving thrombolytic or anticoagulant therapy.
- Currently active bleeding or significant bleeding tendency within 3 months (i.e., patients at high risk of bleeding).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Changzhou Tumor Hospital (Changzhou Fourth People's Hospital)
Changzhou, Jiangsu, 213000, China
Liyang People's Hospital
Changzhou, Jiangsu, 213000, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Huaian First People's Hospital
Huai'an, Jiangsu, 223000, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222000, China
First Affiliated Hospital of Nanjing Medical Unviersity
Nanjing, Jiangsu, 210000, China
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210000, China
Nantong University Cancer Hospital
Nantong, Jiangsu, 226000, China
The First People's Hospital of Nantong
Nantong, Jiangsu, 226000, China
Changshu No.2 People's Hospital
Suzhou, Jiangsu, 215000, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215000, China
Wuxi Huishan District People's Hospital
Wuxi, Jiangsu, 214000, China
Jiangyin People's Hospital
Wuxi, Jiangsu, 214400, China
Xuzhou First People's Hospital
Xuzhou, Jiangsu, 221000, China
Yangzhou University Affiliated Jiangdu People's Hospital
Yangzhou, Jiangsu, 225000, China
Yizheng People's Hospital
Yangzhou, Jiangsu, 225000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician, Department of Medical Oncology
Study Record Dates
First Submitted
May 28, 2026
First Posted
June 3, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
December 15, 2027
Study Completion (Estimated)
August 15, 2028
Last Updated
June 3, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share