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 occurredmore than 12 months after adjuvant chemotherapy;

• at least one measurable lesion;

• received radiotherapy 3 weeks before recruitment, but the lesion undergoingradiotherapy 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 andAST <2.5 × ULN and if liver metastases, BIL < 3 × ULN, ALT and AST <5 × ULN; SerumCr ≤ 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 (NYHAclassification);

• have received anlotinib or other immune checkpoint inhibitor ;

• with known or clinically suspected brain metastases, autoimmune disease, organtransplantation ;

• 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 studyor during participation in the study, with the exception of a dermal basal cell orsquamous cell carcinoma or cervical carcinoma in situ, if these were treatedcuratively.

• 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