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

Naval Military Medical University (Second Military Medical University)

Status and phase

Enrolling

Phase 2

Conditions

Anlotinib

Gastric Cancer

Immunotherapy

Toripalimab

Treatments

Drug: Anlotinib Plus Toripalimab

Study type

Interventional

Funder types

Other

Identifiers

NCT04278222

APICAL-GC

Details and patient eligibility

About

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.

Full description

Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line treatment.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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