FOLFOXIRI-based HAIC Combined With Fuquintinib as Late-line Treatment in Patients With CRLM：A Phase 2 Single-Arm Clinical Trial

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

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 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.

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).