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

NCT ID: NCT04278222

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2024-12-31

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.

Conditions

Gastric Cancer; Immunotherapy; Anlotinib; Toripalimab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anlotinib Plus Toripalimab

the combination of Anlotinib Plus Toripalimab as first-line treatment

Group Type: EXPERIMENTAL

Anlotinib Plus Toripalimab

Intervention Type: DRUG

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

Interventions

Anlotinib Plus Toripalimab

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuan-Sheng Zang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Medical Oncology, Shanghai Changzheng Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ke Liu

Role: primary

45352126@qq.com

+86-18502113721

References

Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

Reference Type: DERIVED

PMID: 35623069 (View on PubMed)

Other Identifiers

APICAL-GC

Identifier Type: -

Identifier Source: org_study_id