TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.
Eligibility Criteria
Inclusion Criteria: 1. Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance; 2. Age ≥18 years old; 3. Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology; 4. After receiving 12 weeks of standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab second-line induction therapy, the patients are confirmed as CR, PR, or SD according to RECIST 1.1 criteria; 5. The interval between the last second-line induction therapy and randomization is not more than 6 weeks; 6. At least one measurable lesion according to RECIST 1.1 criteria; 7. ECOG Performance Status 0-2; 8. Estimated life expectancy ≥12 weeks; 9. Adequate major organ function (no medication for blood component, cell growth factor correction therapy is allowed within 14 days before randomization); 10. Women of child-bearing potential must agree to abstain from sex (heterosexual intercourse) or use a reliable, effective method of contraceptio