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

July 9, 2024 updated by: Yuan-Sheng Zang, Shanghai Changzheng Hospital

Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Department of Medical Oncology, Shanghai Changzheng Hospital
        • Contact:
        • Principal Investigator:
          • Yuan-Sheng Zang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib Plus Toripalimab
the combination of Anlotinib Plus Toripalimab as first-line treatment
Drug: Anlotinib Plus Toripalimab
Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: 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
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: Through study completion, an average of 4 weeks
Incidence of Treatment-related adverse Events
Through study completion, an average of 4 weeks
Progress Free Survival
Time Frame: 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
Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks
Overall Survival
Time Frame: 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
From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks
Deepness of response
Time Frame: 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
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Disease control rate
Time Frame: 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
Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APICAL-GC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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