Phase II Clinical Study of Fruquintinib Combined TAS102 for Second-line Treatment of Advanced Gastric Cancer

Tianjin Medical University Cancer Institute and Hospital1 site in 1 country30 target enrollmentNovember 10, 2023

ConditionsGastric Cancer

InterventionsFruquintinib, TAS102

DrugsFruquintinib, TAS102

Overview

Phase: Not Applicable
Intervention: Fruquintinib, TAS102
Conditions: Gastric Cancer
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: Progression Free Survival
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib combined with TAS102 for second-line treatment of advanced gastric cancer.

Detailed Description

A prospective study of Fruquintinib combined with TAS-102 for the posterior line treatment of advanced colorectal cancer is ongoing (NCT05004831). Both Fuquinitinib and TAS-102 are oral drugs, which are convenient to use and avoid the burden of frequent hospitalization. Whether this combination has considerable efficacy in gastric cancer is not clear.

Registry

clinicaltrials.gov

Start Date

November 10, 2023

End Date

October 10, 2026

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old.
•The ECOG score is 0-1 and does not deteriorate within 7 days.
•Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.
•Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.
•Measurable lesions that meet RECIST 1.1 criteria.
•Have adequate organ and bone marrow function, laboratory tests meet the following requirements:
•NEUT≥1.5×10\^9/L;
•PLT ≥80×10\^9/L;
•TBIL≤1.5 times upper limit of normal value (ULN);
•ALT and AST≤2.5 x ULN; In liver metastasis, ALT and AST≤5×ULN;

Exclusion Criteria

•Previous treatment with VEGFR inhibitors;
•Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the disease progression);
•Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
•Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
•Previously received allogeneic bone marrow transplantation or organ transplantation;
•Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
•Had any disease or condition affecting drug absorption before enrollment, or the patient could not take drugs orally;
•Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unexcised tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
•Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \> 30 mL, hematemesis, stool, stool blood), hemoptysis, or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
•Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \> Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \< 50%;

Arms & Interventions

Fruquintinib combined with TAS102

Fruquintinib 4mg d1-21, q4w TAS102 35mg/m2，bid，d1-5，d15-19，q4w

Intervention: Fruquintinib, TAS102

Outcomes

Primary Outcomes

Progression Free Survival

Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Time from the start of treatment to the progression of the disease

Secondary Outcomes

Overall survival(From date of randomization until the date of death from any cause or the last visit date, whichever came first, assessed up to 60 months)
The Overall Response Rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
Disease Control rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)