Clinical trial NCT07024537: HAIP Combined With Fuquinitinib as Late-line Treatment in Patients With CRLM：A Phase 2 Single-Arm Clinical Trial
Official title: Hepatic Arterial Infusion Pump (HAIP) Combined With Fuquinitinib as Late-line Treatment in Patients With Colorectal Cancer Liver Metastases（CRLM）: A Phase 2 Single-Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Colorectal Neoplasms
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: objective response rate
timeFrame: 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:
measure: overall progression-free survival (PFS)
timeFrame: 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.
measure: overall survival (OS)
timeFrame: From date of the first treatment until the date of date of death from any cause,assessed up to 100 months.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Meng Qiu, Professor
role: PRINCIPAL_INVESTIGATOR
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