Efficacy of Modified Fruquintinib in Colorectal Cancer Liver Metastases: A Phase II Study

The overall 5-year survival rate for patients with colorectal liver metastases (CRLM) is still less than 20%. Surgery-based local treatment can achieve no evidence of disease (NED) in CRLM patients, but over 60% of patients experience recurrence even after achieving NED. Even with adjuvant therapy for the 6-month perioperative period after achieving NED, the recurrence rate remains high. Fruquintinib is a selective anti-angiogenic inhibitor that may help reduce tumor recurrence and prolong the time to recurrence and metastasis. The Chinese Society of Clinical Oncology (CSCO) guidelines have recommended fruquintinib as a third-line therapy for colorectal cancer. This study aims to evaluate the effectiveness and safety of fruquintinib as a maintenance therapy for patients with advanced colorectal cancer (CRC) who have achieved no evidence of disease (NED) after completing adjuvant chemotherapy.

NCT Number	NCT06018714
Lead Sponsor	Sun Yat-sen University
Conditions	Colorectal Cancer Metastatic
Enrollment	64 participants
Start Date	2023-05-01
Primary Completion	2024-08-01 (estimated)
Study Completion	2026-08-01 (estimated)
Updated on ClinicalTrials.gov	2023-08-31