The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer

The Second Affiliated Hospital of Shandong First Medical University1 site in 1 country50 target enrollmentOctober 15, 2023

ConditionsColorectal Cancer

InterventionsTas-102(Suyuan) combined with bevacizumab

DrugsTas-102(Suyuan) combined with bevacizumab

Overview

Phase: Phase 2
Intervention: Tas-102(Suyuan) combined with bevacizumab
Conditions: Colorectal Cancer
Sponsor: The Second Affiliated Hospital of Shandong First Medical University
Enrollment: 50
Locations: 1
Primary Endpoint: Progression Free Survival
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy

Registry

clinicaltrials.gov

Start Date

October 15, 2023

End Date

October 15, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The Second Affiliated Hospital of Shandong First Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years
•Life expectancy of at least 3 months
•Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
•Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;
•Patients who can not or can not tolerate combination chemotherapy.
•ECOG performance status was PS ≤2;
•According to RECIST Version 1.1, at least 1 measurable metastatic lesion was present;
•Appropriate organ function according to laboratory test values obtained within 7 days prior to administration of the study drug on Day 1 of Cycle
•A .The hemoglobin value was more than 90 g/L. B. The absolute neutrophil count was \> 1.500 MM
•C. Platelet count was \> GT; 100,000/mm (\> GT; 100 \* 10 ° L) . D. Total serum bilirubin was 1.5 x upper limit of normal (ULN) . E.Don't L-aspartic Acid aminotransferase (asgot) and endolaminic aminotransferase (Alt SGPT)≤2.5 x upper limit of normal (ULN) , and AST and ALT ≤5 x ULN if abnormal liver function is due to basal liver metastasis.

Exclusion Criteria

•The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:
•the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,
•the known presence of brain or pial metastases,
•systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
•clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
•uncontrolled diabetes;
•patients who have experienced any arterial thrombosis, embolism, or ischemic or hemorrhagic disease in the last 6 months and have not improved after appropriate treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accident after treatment,
•severe/unstable angina, NYHA Class III or IV symptomatic congestive heart failure,
•clinically significant gastrointestinal bleeding,
•known presence of human immunodeficiency virus (HIV) or acquired conventional immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,