A Study on the Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer

Beijing Friendship Hospital1 site in 1 country30 target enrollmentJanuary 1, 2018

ConditionsGastric Cancer

InterventionsCamrelizumab for injection, apatinib mesylate and tegio

DrugsCamrelizumab for injection, apatinib mesylate and tegio

Overview

Phase: Phase 2
Intervention: Camrelizumab for injection, apatinib mesylate and tegio
Conditions: Gastric Cancer
Sponsor: Beijing Friendship Hospital
Enrollment: 30
Locations: 1
Primary Endpoint: DFS
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, single-center, single-arm, open-label clinical study, aiming at evaluating the efficacy and safety of camrelizumab for injection, apatinib mesylate and tegio for first-line refractory patients with advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

January 1, 2018

End Date

June 30, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Friendship Hospital

Responsible Party

Principal Investigator

Zhongtao Zhang

Professor

Beijing Friendship Hospital

Eligibility Criteria

Inclusion Criteria

•Aged 18-75;
•ECOG score 0-2;
•Pathologically diagnosed late-stage adenocarcinoma of stomach or gastroesophageal junction, with extra-gastric measurable lesions (spiral CT scan≥10 mm, meeting RECIST 1.1 criteria);
•Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy;
•Patients who received no previous treatment with apatinib or other VEGFR inhibitors, e.g. sorafenib and sunitinib;
•Normal blood routine examination: Neutrophil count ≥ 1.5 × 109 / L; Hemoglobin ≥ 80 g / L; Platelet count ≥ 100 × 109 / L; Total bilirubin ≤ 1.5 × ULN; ALT, AST≤2.5×ULN；
•Without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection.

Exclusion Criteria

•KPS \< 60, or estimated survival \< 3 months;
•Patients with cardiovascular and cerebrovascular events within half a year; patients with uncontrollable hypertension (systolic pressure \> 140 mmHg, diastolic pressure \> 90 mmHg), coronary heart disease above grade I, arrhythmia (including QTc interval prolongation \> 450 ms in men, 470 MS in women) and grade I cardiac dysfunction; patients positive of urine albumin;
•Patients with definite tendency of gastrointestinal bleeding, local active ulcer focus, and occult blood in stool (+ +); patients with history of black stool and hematemesis within 2 months;
•Abnormal coagulation (INR \> 1.5, APTT \> 1.5 ULN), with bleeding tendency;
•Patients with factors that can affect the absorption of oral-intake drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
•Patients with nervous and mental diseases or with severe infection;
•Pregnant or lactating women or those who have fertility requirements during the study period.