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

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: Camrelizumab for injection, apatinib mesylate and tegio

• Registration Number: NCT04345783
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-12
• Last Update Submitted: 2020-04-12
• Study First Posted: 2020-04-14
• Last Update Posted: 2020-04-14
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. Aged 18-75;
• 2. ECOG score 0-2;
• 3. 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);
• 4. Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy;
• 5. Patients who received no previous treatment with apatinib or other VEGFR inhibitors, e.g. sorafenib and sunitinib;
• 6. 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；
• 7. Without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection.

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Exclusion Criteria

• 1. KPS < 60, or estimated survival < 3 months;
• 2. 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;
• 3. 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;
• 4. Abnormal coagulation (INR > 1.5, APTT > 1.5 ULN), with bleeding tendency;
• 5. 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.);
• 6. Patients with nervous and mental diseases or with severe infection;
• 7. Pregnant or lactating women or those who have fertility requirements during the study period.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Camrelizumab+Apatinib Mesylate+Tegio	Camrelizumab for injection, apatinib mesylate and tegio	-

Primary Outcome Measures

Name	Time	Method
DFS	3 years	disease free survival
OS	3 years	overall survival

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China