TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer : An Open-label 、Phase Ⅱ Clinical Trial

Fujian Cancer Hospital1 site in 1 country25 target enrollmentApril 1, 2022

ConditionsImmunotherapy Colorectal Cancer

InterventionsTislelizumab bevacizumab TAS-102

DrugsTislelizumab bevacizumab TAS-102

Overview

Phase: Phase 2
Intervention: Tislelizumab
Conditions: Immunotherapy
Sponsor: Fujian Cancer Hospital
Enrollment: 25
Locations: 1
Primary Endpoint: progression free survival
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis.

Registry

clinicaltrials.gov

Start Date

April 1, 2022

End Date

February 28, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fujian Cancer Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who provided informed consent and voluntarily enrolled
•Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;
•18-75 years old;
•Measurable target lesions according to RECIST V1.1 assessment criteria;
•Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);
•0 \~ 2 points according to ECOG quality of life score;
•Drugs can be taken orally
•Estimated survival ≥3 months;
•Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
•Ascites with no obvious symptoms and no clinical intervention;

Exclusion Criteria

•Previous application of TAS-102;
•Pregnant or lactating women;
•No contraception during the reproductive period;
•patients known to have a history of allergy to any study drug, similar drug or excipient;
•Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
•Patients with a history of thromboembolism, except those caused by PICC;
•Patients with active infection;
•Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg);
•Patients with brain metastases with clinical symptoms or imaging evidence;
•Contraindications for treatment of other chronic diseases;