NCT05406206

Hepatic Arterial Infusion Chemotherapy With Fruquintinib for Colorectal Cancer Liver Metastases As Third-line Therapy

A Phase II Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Fruquintinib as Third-line Therapy for Patients With Unresectable Colorectal Cancer Liver Metastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Fruquintinib (HMPL-013) is a novel oral small molecule that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts. Combined with hepatic arterial infusion chemotherapy (HAIC), this study is conducted to assess the efficacy and safety of this regimen in patients with unresectable colorectal cancer liver metastases as the third-line therapy.

Detailed description

This will be a single-arm, open-label, phase II study. This study will be divided into 2 stages: dose exploration and dose expansion. In the dose exploration stage, "3+3 dose escalation" design will be applied to determined the maximum tolerated dose (MTD) of fruquintinib for next stage: Cohort A: HAIC + fruquintinib 3mg QD, 3 weeks on/1 week off (3w/1w). Cohort B: HAIC + fruquintinib 4mg QD, 3w/1w. Cohort C: HAIC + fruquintinib 5mg QD, 3w/1w. All subjects of this study will be permitted to continue therapy with only safety monitoring and assessments for progression, if the product is well tolerated and the subject has stable disease or better.

Conditions

• Advanced Colorectal Carcinoma
• Liver Metastasis Colon Cancer

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib is a capsule in the form of 1mg and 5mg, once a day, 3 week on/1 week off.
PROCEDURE	Hepatic Arterial Infusion Chemotherapy	HAIC is a locoregional therapy for colorectal cancer liver metastasis. Oxaliplatin 85 mg/m\*2 + 5-FU 2000 mg/m\*2, Q4W

Timeline

• Start date: 2022-02-25
• Primary completion: 2023-07-31
• Completion: 2024-10-31
• First posted: 2022-06-06
• Last updated: 2022-06-06

Locations

1 site across 1 country: China