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FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

NCT07446465 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-03

No results posted yet for this study

Summary

To evaluate the efficacy and safety of immune checkpoint inhibitor-based combination therapy with targeted therapy and chemotherapy in patients with locally advanced unresectable or metastatic colorectal cancer.

Conditions

  • Colorectal Cancer (Locally Advanced or Metastatic)
  • Colorectal Cancer Microsatellite Stable (MSS)

Interventions

DRUG

Serplulimab

Serplulimab: 200 mg IV Day 1, q2w

DRUG

Fruquintinib

Fruquintinib: 4 mg orally once daily, Days 1-21, every 4 weeks

DRUG

mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Oxaliplatin 85 mg/m² IV q2w Leucovorin 400 mg/m² IV q2w 5-FU 400 mg/m² IV bolus Day 1 5-FU 1200 mg/m²/day continuous IV infusion Days 2-3

Sponsors & Collaborators

  • Ye Xu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07446465 on ClinicalTrials.gov