Fruquintinib With or Without HAI-FOLFOX for Refractory Colorectal Cancer

NCT06441565 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-07-30

No results posted yet for this study

Summary

The objective of this clinical trial is to evaluate the efficacy and safety of combining fruquintinib with hepatic artery infusion (HAI)-FOLFOX in the treatment of refractory colorectal cancer with liver metastasis.

Conditions

Interventions

DRUG

Fruquintinib

A treatment cycle of 4 weeks, with 5 mg orally once daily for 3 weeks, followed by a 1-week break

DRUG

Fluorouracil

2.8 g/m² (400mg bolus + 2.4g/m² continuous infusion) given every 2 weeks through hepatic arterial infusion

DRUG

Oxaliplatin

85 mg/m² given every 2 weeks through hepatic arterial infusion

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2025-12-30
Completion
2029-12-30

Countries

  • China

Study Locations

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Entities

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 NCT06441565 on ClinicalTrials.gov