Toripalimab Combined With Anlotinib for Patients With Advanced, Relapsed, or Refractory Gastric, or Esophagogastric Junction Cancer (EGJC)

June 29, 2021 updated by: zhangxiaochun, The Affiliated Hospital of Qingdao University

The Affiliated Hospital of Qingdao University

Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function. The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded. This study was an open, exploratory single-arm, phase II trial. Enrolled patients received anlotinib (12mg, po. qd, d1-14) combined with toripalimab (240 mg, inv, over 30 min once every 2 weeks).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

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

Study Contact

Study Locations

  • China
      • Qingdao, China, 266003
        • Recruiting
        • Xiaochun Zhang
        • Contact:

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy.

Description

Inclusion Criteria:

Patients were aged >18 years with histological confirmed GC/EGJC and were refractory to the first line of therapy. Additional eligibility requirements included: ≥1 measurable disease at baseline per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v 1.1); Eastern Cooperative Oncology Group Performance status of 0 or 1; or life expectancy of ≥ 3 months and adequate organ function.

Exclusion Criteria:

The main exclusion criteria were interstitial lung disease, pulmonary fibrosis, active or prior autoimmune disease or active hepatitis, or history of anlotinib or any other PD-L1/PD-1 antagonist treatment. Patients with abdominal fistula, diverticulitis, gastrointestinal ulcerative disease or perforation, or abdominal abscess within the prior 4 weeks were also excluded.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with CPS ≥ 1 or MSI-H or TMB ≥ 10Mb/MUT
Genetic: FGFR2
Mutation of FGFR2
patients with CPS =0 , MSS and TMB < 10Mb/mut
Genetic: FGFR2
Mutation of FGFR2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ORR
Time Frame: 01.01.2019 to 01.01.2021
01.01.2019 to 01.01.2021
6m-PFS
Time Frame: 01.01.2019 to 01.01.2021
01.01.2019 to 01.01.2021
safety
Time Frame: 01.01.2019 to 01.01.2021
01.01.2019 to 01.01.2021

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS
Time Frame: 01.01.2019 to 01.01.2021
01.01.2019 to 01.01.2021
OS
Time Frame: 01.01.2019 to 01.01.2021
01.01.2019 to 01.01.2021

Collaborators and Investigators

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

Sponsor

The Affiliated Hospital of Qingdao University

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)

January 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

January 14, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAANGC/EJGC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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