Phase II Trial of Fruquintinib and Cetuximab-beta Combination for Third-Line Treatment in RAS Wild-Type Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the combination of fruquintinib, an oral anti-angiogenesis drug, and cetuximab-beta, an anti-EGFR antibody, for patients with RAS wild-type metastatic colorectal cancer who have already undergone at least two lines of standard treatments. This Phase II study focuses on patients whose cancer has progressed after therapies such as fluorouracil, oxaliplatin, and irinotecan. The goal is to assess how well these two drugs work together and their safety profile in this patient group. Participants will take fruquintinib orally once daily for 3 weeks followed by a 1-week break, in repeated 4-week cycles. Cetuximab-beta will be given through intravenous infusion every 2 weeks. Treatment will continue until the cancer progresses or side effects become unacceptable. Tumor assessments will be done every 8 weeks using CT or MRI scans, and blood samples will be collected over time to measure circulating tumor DNA, which helps track treatment response and resistance. Throughout the study, doctors will monitor safety through physical exams, lab tests, vital signs, ECG, echocardiography, and report any side effects. The main measurement is the objective response rate, which looks at how many patients experience tumor shrinkage. Secondary goals include progression-free survival, disease control rate, overall survival, and safety outcomes. The study plans to enroll 46 patients and treatment may last up to 24 months with follow-up continuing up to 36 months.

Fruquintinib Plus Anti-EGFR Antibody for Third-Line Treatment of RAS Wild-Type mCRC