Study of Regorafenib Combined With Metronomic Chemotherapies and Low-dose Aspirin Followed by Standard Chemotherapy for Second-Line Treatment of Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the use of regorafenib combined with metronomic chemotherapies and low-dose aspirin as a two-month induction treatment before starting standard second-line chemotherapy in patients with metastatic colorectal cancer. This open-label, randomized Phase II-III study aims to assess this combinations impact on tumor response and overall survival compared to standard chemotherapy alone. Participants in the experimental group will receive regorafenib administered three weeks out of four for two months using a dose-escalation schedule, along with continuous oral capecitabine and cyclophosphamide and daily low-dose aspirin. After this induction phase, they will proceed to standard second-line chemotherapy with bevacizumab plus either FOLFOX or FOLFIRI regimens. The control group will receive only the second-line chemotherapy. Treatments are given according to investigator practice until disease progression or unacceptable toxicity. During the study, participants will undergo regular assessments including blood samples for plasma and circulating tumor DNA, imaging scans to measure tumor response by RECIST criteria, and quality of life questionnaires EORTC QLQ-C30, CR29, EQ-5D3L. Researchers will monitor the best objective tumor response over about 14 months and overall survival up to 64 months. Safety and treatment tolerability will also be evaluated throughout the trial.

Regorafenib With Low-dose Chemotherapies and Aspirin Followed by Standard Chemotherapies in Metastatic Colorectal Cancer