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Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
NCT06856187 · Fudan University
In plain English
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Official title
A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
About this study
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.
Study design
Enrollment target: 119 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-02-28
Estimated completion: 2027-04-30
Last updated: 2025-08-06
Interventions
Drug: TAS-102+bevacizumab+local treatmentDrug: Standard chemotherapy
Primary outcomes
- • Time to treatment failure (TTF) (up to approximately 2 years.)
Sponsor
Fudan University · other
Contacts & investigators
ContactWenhua Li, Ph.D · contact · whliiris@hotmail.com · 8618017317210
ContactWenhua Li, Ph.D · contact · whliiris@hotmail.com · 86 18017317210
All locations (1)
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, Shanghai Municipality, China