NCT06856187 Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 119 participants in total. It began in 2025-02-28 with a primary completion date of 2026-06-30.

Brief 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.

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.

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