Gastric Cancer
Conditions
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.
Interventions
DRUGCamrelizumab for injection, apatinib mesylate and tegio
Camrelizumab for injection: fixed dose of 200 mg, ivgtt for 30 minutes, given on D1, repeat for every 3 weeks; Apatinib mesylate: 250 mg, p.o, qd; Tegio capsule: p.o., bid, D1-14, repeat for every 21 days.
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS | 3 years | disease free survival |
| OS | 3 years | overall survival |
Countries
China
Outcome results
None listed