gastric cancer
Conditions
Interventions
Group A:PD-1 monoclonal antibody plus chemotherapy
Group B:apatinib plus chemotherapy
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Had histologically confirmed unresectable and/or metastatic adenocarcinoma of the stomach or gastroesophageal junction; 3. With measurable and/or evaluable (including unmeasurable) lesions or patients with locally advanced unresectable lesions during first-line chemotherapy; 4. Failed of first-line and second line chemotherapy(including DCF, XP, XELOX, Sox, SP, ECF and modified ECF, FOLFOX and FOLFIRI regimens) might contain a PD-1/PD-L1/CTLA-4 monoclonal antibody; 5. More than 3 weeks elapsed from the last chemotherapy to enrollment; 6. ECOG score 0-2; 7. Within one week before enrollment, adequate organ function as defined below: (1) Hematologic ANC >= 1.5*10^9/L; (2) Platelets >= 75*10^9/L; (3) Hemoglobin (HB) >= 80g/L; (4) AST and ALT <= 2.5×ULN; (5) TBIL <= 1.5×ULN (6) Serum creatinine (CR) <= 1.5ULN; 8. Subjects voluntarily join the study and sign the Informed Consent Form for the study; 9. Patients with good compliance and can be followed up, able to cooperate with related examination and treatment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast feeding women; 2. Received two or more palliative immunotherapy regimens before enrollment; 3 .Female patients during childbearing age did not agree to take effective contraceptive methods; 4. Pathologically classified not adenocarcinoma (such as leiomyosarcoma and lymphoma); 5. Simultaneously with other cancers, but not cervical carcinoma in situ and skin basal cell carcinoma or squamous cell carcinoma; 6. Brain or meningeal metastasis, intestinal obstruction, or symptomatic peripheral neuropathy (NCIC-CTC grade > 3); 7. Have active bleeding, fecal occult blood more than 2+; 8. With multi-drug allergy; 9. Have factors affecting oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 10.With the following serious diseases: (1) Serious heart disease, myocardial infarction, congestive heart failure, unstable angina pectoris, unstable arrhythmia occurred within 6 months, etc.; (2) Definite neuropathy or psychosis; (3) Uncontrolled infection; (4) Active disseminated intravascular coagulation; (5) Autoimmune diseases; 11.With grade 3 adverse effection reactions in previous immune therapy or previous treatment of apatinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective Response Rate, ORR;Quality of Llife; | — |
Countries
China
Contacts
Public ContactZhang Dexiang
Shanghai Xuhui Central Hospital
Outcome results
None listed