Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)

Inclusion Criteria: * Histologically confirmed, UICC stage IV gastric cancer; * no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy; * at least one measurable lesion; * received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria; * ECOG performance status 2; * the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN), ALT and AST \<2.5 × ULN and if liver metastases, BIL \< 3 × ULN, ALT and AST \<5 × ULN; Serum Cr ≤ 1.5 × ULN; * Patient's written declaration of consent obtained; * Estimated life expectancy \> 3 months; Exclusion Criteria: * harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive; * dMMR/MSI-H; * Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification); * have received anlotinib or other immune checkpoint inhibitor ; * with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ; * severe wounds or surgery 4 weeks before recruitment; * received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents; * History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively. * pregnancy or breast feeding; * absent or restricted legal capacity; * a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study