FOLFOXIRI-based HAIC Combined With Fuquintinib as Late-line Treatment in Patients With CRLM：A Phase 2 Single-Arm Clinical Trial (HAIC，CRLM)

April 26, 2026 updated by: Meng Qiu

FOLFOXIRI-based Hepatic Arterial Infusion Combined With Fuquintinib as Late-line Treatment in Patients With Colorectal Cancer Liver Metastase: A Phase 2 Single-Arm Clinical Trial

This study was a phase 2, single-arm, single-center clinical trial in which previously treated patients with unresectable colorectal cancer liver metastases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with fruquintinib in later treatment for colorectal cancer liver metastases. All patients received FOLFOXIRI-based HAIC chemotherapy and oral fruquintinib. The primary end point was objective response rate (ORR), and the secondary endpoints were disease control rate (DCR), the liver-specific ORR, overall survival (OS), progression-free survival (PFS), liver-specific PFS, duration of response(DoR)and safety.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 75 years;
  • Histologically or cytologically confirmed CRLM;
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2;
  • Prior failure of at least second-line of systemic therapy (fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens, anti-EGFR therapy for RAS wild-type tumors and/or anti-VEGF therapy);
  • At least one measurable intrahepatic target lesion according to RECIST V1.1 criteria;
  • Normal major organ function(liver, kidney, heart, and lungs);
  • Patients with limited extrahepatic metastases (defined as up to 3 metastatic lesions in a single organ system) were eligible for inclusion.

Exclusion Criteria:

  • Previous treatment with transarterial chemoembolization (TACE) or HAIC; prior use of fruquintinib;
  • A history of another malignancy within 5 years prior to enrollment, except for adequately treated non-melanoma skin cancer or in situ carcinoma, carcinoma in situ of the cervix, or gastrointestinal tumors treated curatively with endoscopic mucosal resection;
  • Allergy to the study drug;
  • Severe dysfunction of major organs (liver, kidney, heart, or lungs).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A Phase II Single-Arm Clinical Trial
all enrolled patients without surgical contraindications underwent hepatic artery port implantation by an interventional physician.All patients received oral fruquintinib at an initial dose of 4 mg once daily from day 1 to day 21 of each 28-day cycle. Patients received drug infusion via the hepatic artery: Oxaliplatin 85 mg/m² and Leucovorin 400 mg/m² infused via arterial pump over 2 hours on day 1, Irinotecan 150 mg/m² infused via arterial pump over 90 minutes on day 1,and 5-Fluorouracil 2400 mg/m² infused via arterial pump over 46 hours, repeated biweekly until disease progression, patient's refusal, unacceptable toxic effects, or withdrawal of consent.
Drug: FOLFOXIRI-based HAIC+Fuquinitinib
All patients received oral fruquintinib at an initial dose of 4 mg once daily from day 1 to day 21 of each 28-day cycle, and FOLFOXIRI-HAIP chemotherapy with Oxaliplatin 85 mg/m² and Leucovorin 400 mg/m² infused via arterial pump over 2 hours on day 1, Irinotecan 150 mg/m² infused via arterial pump over 90 minutes on day 1,and 5-Fluorouracil 2400 mg/m² infused via arterial pump over 46 hours, repeated biweekly until disease progression, patient's refusal, unacceptable toxic effects, or withdrawal of consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: The best evaluation of clinical efficacy from the time of the first initiation of treatment until the patient's disease progression to change of treatment or death, assessed up to 100 months.
ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.
The best evaluation of clinical efficacy from the time of the first initiation of treatment until the patient's disease progression to change of treatment or death, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall progression-free survival (PFS)
Time Frame: From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
PFS is defined as the time from the initiation of treatment until disease progression or death.
From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Duration of Response(DoR)
Time Frame: From date of first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first. the assessed up to 100 months.
DoR was defined as time from first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first.
From date of first occurrence of complete or partial response until date of radiographical disease progression or death, whichever occurred first. the assessed up to 100 months.
Disease control rate(DCR)
Time Frame: From date of the first treatment until the date of date of death from any cause or experiment stopped, whichever came first, assessed up to 100 months.
The proportion of patients with a best overall response of achieved complete response, partial response or stable disease.
From date of the first treatment until the date of date of death from any cause or experiment stopped, whichever came first, assessed up to 100 months.
Overall survival (OS)
Time Frame: From date of the first treatment until the date of date of death from any cause, whichever came first, assessed up to 100 months.
OS was defined as the time from study enrollment to death from any cause.
From date of the first treatment until the date of date of death from any cause, whichever came first, assessed up to 100 months.
Liver-specific PFS
Time Frame: From date of the first treatment until the date of first documented liver progression or date of death from any cause, whichever came first, assessed up to 100 months.
Liver-specific PFS was defined analogously to PFS, but considering only progression events occurring within the liver.
From date of the first treatment until the date of first documented liver progression or date of death from any cause, whichever came first, assessed up to 100 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meng Qiu

Investigators

  • Principal Investigator: Meng Qiu, Professor, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2023

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

May 26, 2025

First Submitted That Met QC Criteria

June 12, 2025

First Posted (Actual)

June 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Approval No. 380, 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

First of all, there is a lack of sufficient funds or personnel to anonymize and maintain the data for a long time, such as the original imaging documents, which are difficult to organize compliance. Second, this study was an early exploratory study with small data size and high risk of identification. Finally, summary results are available after publication, and the data will be reassessed 5 years after the end of the study.

Study Data/Documents

  1. Analytic Code
    Information identifier: Statistical analysis
    Information comments: The Kaplan-Meier method was used to analyze OS and PFS in the overall population with estimated medians and 95% CIs presented. Survival curves were performed using R software version 4.2.2 (http://www.Rproject.org).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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