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

Launched by FUDAN UNIVERSITY · Feb 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with advanced colorectal cancer that cannot be surgically removed. Specifically, the study is comparing two types of treatments: a combination of TAS-102 and bevacizumab, along with local treatment, versus a standard continuous second-line therapy. The goal is to see if the new combination is more effective and safe for patients who have not responded well to their initial treatment.

To participate in this trial, patients need to have a confirmed diagnosis of colorectal cancer that has spread and cannot be removed by surgery. They should have already tried one type of standard treatment but did not have success with it, and they must have at least one measurable tumor. Eligible patients will be closely monitored throughout the trial and will need to sign consent forms to join. It's important to note that there are specific health conditions and recent treatments that could exclude someone from participating, so discussing eligibility with a healthcare provider is key.

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ALL

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.