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NCT Number: NCT07024537

FOLFOXIRI-based HAIC Combined With Fuquintinib as Late-line Treatment in Patients With CRLM：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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

FOLFOXIRI-based HAIC+Fuquinitinib

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Meng Qiu

Other

Registry information

Official study title

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

Acronym: HAIC，CRLM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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