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

Shanghai Changzheng Hospital24 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer Immunotherapy Anlotinib Toripalimab

Interventions

Anlotinib Plus ToripalimabDRUG

Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

objective response rate

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Secondary Outcomes

Progress Free Survival

Time from treatment beginning until disease progression

Time frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks

Overall Survival

Time from treatment beginning until death from any cause

Time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks

Deepness of response

Investigation of depth of response during first-line treatment

Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Disease control rate

Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease

Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

adverse events

Incidence of Treatment-related adverse Events

Time frame: Through study completion, an average of 4 weeks

Data from ClinicalTrials.gov

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