second-line standard treatment sequential tas-102 and bevacizumab combined with local treatment in advanced colorectal cancer

Conditions: Metastatic Colorectal Cancer (CRC)

Summary: 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.

Eligibility criteria:
inclusion criteria: * 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; * estimated life expectancy ≥3months; * adequate major organ function; * subjects voluntarily participate in this study, sign the informed consent form, and have good compliance. exclusion criteria: * 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); * known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed); * serious illness, including but not limited to the following: 1. patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix; 2. known brain and/or leptomeningeal metastases; 3. active infection or fever of unknown origin \> 38.5 ° c ; 4. poorly controlled hypertension (systolic blood pressure \>150 mmhg and/or diastolic blood pressure \>100 mmhg) with a previous history of hypertensive crisis or hypertensive encephalopathy; 5. known inherited or acquired bleeding (e.g., coagulopathy) 6. thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment; 7. severe, unhealed or dehiscence wounds and active ulcers or untreated fractures; 8. myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (nyha class iii or iv) within the last 12 months; 9. acute or subacute intestinal obstruction, or chronic inflammatory bowel disease; 10. there are serious psychological or psychiatric abnormalities that affect the compliance of patients to participate in this clinical study. * has undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study or is expected to undergo major surgical treatment during the study period; * inability to swallow pills, presence of malabsorption syndrome or any condition affecting gastrointestinal absorption; * the investigator assessed that it is not appropriate to participate in the study.

Keywords: colorectal cancer tas-102 second-line therapy maintainance therapy