Phase II Open-Label Study of Oral Fruquintinib with FOLFIRI for Adults with Metastatic Colorectal Cancer as Second-Line Treatment

What this Trial Is About

Researchers are evaluating the combination of fruquintinib and FOLFIRI as a second-line treatment for adults with metastatic colorectal cancer mCRC. This open-label Phase II trial focuses on assessing the effectiveness and safety of this combination in participants previously treated with first-line therapies including oxaliplatin, fluoropyrimidine, and bevacizumab. The study excludes those with certain genetic mutations and aims to enroll up to 60 participants. Participants will receive fruquintinib orally for 21 days followed by a 7-day break in each 28-day cycle. Concurrently, they will receive FOLFIRI intravenously every 2 weeks within each cycle. Treatment continues until disease progression or unacceptable side effects. The FOLFIRI regimen includes irinotecan, leucovorin, and 5-fluorouracil, with possible adjustment to the 5-fluorouracil bolus based on prior treatment tolerance. During the study, participants will be closely monitored with assessments every two cycles 56 days including progression-free survival evaluation, response rates, duration of response, disease control, and overall survival. Safety is tracked through adverse event monitoring from consent to 30 days after treatment ends, up to one year. The total study duration for each participant may last up to two years to fully capture treatment outcomes and safety data.

A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)