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.
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. In this study, 119 metastatic colorectal cancer patients who reach CR/PR/SD after 3 months second-line treatment will be randomized to receive sequential TAS-102 +bevacizumab combined with local treatment or continuous treatment of previous second-line therapy. The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, PFS, OS, safety and patient reported outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
patients 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 therapy:FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGTime 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.
Time frame: up to approximately 2 years.
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.
Time frame: up to approximately 2 years.
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).
Time frame: up to approximately 2 years.
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.
Time frame: up to approximately 2 years.
Overall survival(OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Time frame: up to approximately 2 years.
Adverse Events
AE assessed by NCI-CTCAE v5.0.
Time frame: up to approximately 2 years.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) during study treatment. The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.
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Time frame: up to approximately 2 years.
Progression-free survival(PFS2)
PFS2 is defined as the time from receiving second-line standard therapy until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Time frame: up to approximately 2 years.