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

Phase 2

Recruiting

• Conditions: Toripalimab; Gastric Cancer; Anlotinib; Immunotherapy
• Interventions: Drug: Anlotinib Plus Toripalimab

• Registration Number: NCT04278222
• Lead Sponsor: Shanghai Changzheng Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib Plus Toripalimab	Anlotinib Plus Toripalimab	the combination of Anlotinib Plus Toripalimab as first-line treatment

Primary Outcome Measures

Name	Time	Method
objective response rate	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Secondary Outcome Measures

Name	Time	Method
Progress Free Survival	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks	Time from treatment beginning until disease progression
Overall Survival	From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks	Time from treatment beginning until death from any cause
Deepness of response	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks	Investigation of depth of response during first-line treatment
Disease control rate	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks	Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease
adverse events	Through study completion, an average of 4 weeks	Incidence of Treatment-related adverse Events

Trial Locations

Locations (1)

Department of Medical Oncology, Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China