This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.
Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
Patients who have failed first-line standard therapy and are intended to receive second-line standard therapy;
At least one measurable lesion according to RECIST 1.1 criteria;
ECOG Performance Status 0-1;
Allergy to the investigational drug and/or its excipients;
Pregnant or lactating women;
Prior treatment with TAS-102;
Any CTCAE grade 2 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
Parallel
TAS-102+bevacizumab+local treatment
Drugpatients achieve disease control after second-line induction therapy with standard therapy(FOLFOX/FOLFIRI/XELOX/ mXELIRI＋bevacizumab/cetuximab), then achieve TAS-102+bevacizumab+local treatment
Standard chemotherapy
DrugStandard therapy：FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab
Time to treatment failure (TTF)
TTF is defined as the time from the date of randomization to the date of the discontinuation of the trial protocol.
Objective response rate (ORR)
ORR is defined as the percentage of subjects with complete response (CR) or partial response (PR) by investigator assessment per RECIST criteria, version 1.1.
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD).
Progression-free survival (PFS)
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Overall survival（OS）
OS is defined as the time from the date of randomization to the date of death due to any cause.
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