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Clinical Trials in China / NCT06856187
Recruiting Phase 2

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

NCT06856187 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2025-02-28
Last updated
2025-08-06

Condition(s) studied

Metastatic Colorectal Cancer (CRC)

Investigational drug(s) / intervention(s)

TAS-102+bevacizumab+local treatmentAll Trifluridine/Tipiracil trials (17) →All Bevacizumab trials (238) →Standard chemotherapy

TAS-102+bevacizumab+local treatment: 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 chemotherapy: Standard therapy:FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab

Study 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

Sex
ALL
Min age
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06856187 on ClinicalTrials.gov ↗ ← All trials in China