A Prospective Multi-centered Randomized Controlled Trial on Fruquintinib in Combination With HAIC in the Treatment of Liver Metastatic Colorectal Cancer After Failure of Second-line Systematic Therapy

Colorectal Cancer Clinical Trial

Official title: A Prospective Multi-centered Randomized Controlled Trial on Fruquintinib in Combination With Hepatic Arterial Infusion Chemotherapy (HAIC) in the Treatment of Liver Metastatic Colorectal Cancer After Failure of Second-line Systematic Therapy

Status Recruiting

Clinical Trial Summary

The current study is to investigate the safety and efficacy of fruquintinib combined with HAIC in patients with advanced colorectal liver metastases who have failed second-line systemic standard treatment, in order to provide more survival opportunities for the second progression of advanced colorectal liver metastases.

Clinical Trial Description

Among Chinese colorectal cancer patients, 43.8% had metastasis at the time of diagnosis, of which liver metastasis accounted for 51.5%. In addition, it was reported that 10%-25% of patients developed liver metastasis after radical resection of colorectal cancer, and more than two-thirds of colorectal patients eventually developed liver metastasis. Colorectal liver metastasis was reported to be the most important cause of death in colorectal cancer patients.The median survival time of untreated liver metastases was only 6.9 months, and the 5-year survival rate of unresectable patients was less than 5%, and for unresectable colorectal liver metastasis, the median survival time could reach 30.9 months after comprehensive treatment.

Fruquintinib, a VEGFR 1/2/3 inhibitor, is one of the standard 3rd-line therapy for colorectal cancer, which has already been approved and marketed in China. In phase III FRESCO study, liver metastases subgroup showed that the median OS of fruquintinib group was 8.61 months, which was 2.63 months longer than that of control group, reducing death risk by 41%, with statistically significant P value.

Patients with large tumor burden mainly caused by liver metastasis and with insignificant or refractory response to drug therapy, or patients who cannot tolerate systemic therapy, can be combined with transcatheter arterial chemoembolization (HAI) or transcatheter arterial chemoembolization (TACE) at appropriate time, which helps to prolong the progression-free time and overall survival.

The current study is to investigate the safety and efficacy of fruquintinib combined with HAIC in patients with advanced colorectal liver metastases who have failed second-line systemic standard treatment, in order to provide more survival opportunities for the second progression of advanced colorectal liver metastases. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT05511051
• Study type: Interventional
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2022
• Completion date: December 31, 2024