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ClinicalTrials.gov ID

NCT07622550

Lead Sponsor

Jiangsu Cancer Institute & HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

80Estimated

Last Update Posted

Jun 3, 2026Actual

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Dec 15, 2027Estimated

Completion Date

Aug 15, 2028Estimated

Official Title

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

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.

• Metastatic Colorectal Cancer (CRC)

• Serplulimab+Fruquintinib+XELOX

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Jiangsu Cancer Institute & HospitalOTHER

13626255262

138 1525 9001

136 0616 8002