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

Summary

This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.

Eligibility

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

Conditions5

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