HAIP Combined With Fuquinitinib as Late-line Treatment in Patients With CRLM：A Phase 2 Single-Arm Clinical Trial

Phase 2Active Not RecruitingNCT07024537

Meng Qiu24 enrolled

Overview

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

The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion pump chemotherapy combined with fruquintinib in later treatment for colorectal cancer liver metastases. All patients received FOLFOXIRI-HAIP 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, and safety.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

FOLFOXIRI-HAIP+FuquinitinibDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age between 18 and 75 years; * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2; * Prior treatment with chemotherapy based on oxaliplatin, fluorouracil, and irinotecan, with or without EGFR or VEGFR monoclonal antibodies; * at least one measurable intrahepatic target lesion according to RECIST V1.1 criteria * normal major organ function Exclusion Criteria: * previous treatment with transarterial chemoembolization (TACE) or HAIC;2) prior use of fruquintinib * presence of other systemic primary malignancies, excluding colorectal cancer * allergy to the study drug;5) Severe dysfunction of major organs (liver, kidney, heart, or lungs)

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

objective response rate

ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.

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.

Secondary Outcomes

overall progression-free survival (PFS)

PFS is defined as the time from the initiation of treatment until disease progression or death.

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.

overall survival (OS)

OS is defined as the time from the initiation of treatment until the patient is lost to follow-up or death.

Time frame: From date of the first treatment until the date of date of death from any cause,assessed up to 100 months.

Data from ClinicalTrials.gov

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