Status:
UNKNOWN
Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 refr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04345783
Start Date
January 1 2018
End Date
June 30 2022
Last Update
April 14 2020
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050