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Starting soon Phase 2

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

NCT07622550 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-06-15
Last updated
2026-06-03

Condition(s) studied

Metastatic Colorectal Cancer (CRC)

Investigational drug(s) / intervention(s)

Serplulimab+Fruquintinib+XELOXAll Serplulimab trials (84) →All Fruquintinib trials (51) →All Xelox trials (29) →

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 18 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): 1. Hematology: absolute neutrophil count ≥1.5 × 10⁹/L, platelet count ≥100 × 10⁹/L, hemoglobin ≥90 g/L. 2. International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN. 3. Liver function: total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases). 4. 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 Exclusion Criteria: * \- 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).

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)

FacilityCityRegionStatus
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
Official registry record

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