A Real-world Study of Camrelizumab Alone or in Combination With Apatinib/Chemotherapy for Advanced Gastric Cancer

June 26, 2024 updated by: Changzhi People's Hospital Affiliated to Changzhi Medical College
The purpose of this observational study is to evaluate the safety and efficacy of camrelizumab and apatinib in patients with advanced gastric cancer under real-life conditions, particularly in various subgroups of gastric cancer patients, with a view to providing information about the treatment modalities and efficacy of the treatment in real-life gastric cancer patients and to explore the possible predictive biomarkers of prognosis.Patients, who had both decided to be treated with camrelizumab or apatinib prior to enrollment, were entered into one of the following three cohorts at the discretion of the investigator, based on their disease stage and prior treatment

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

504

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
    • Shanxi
      • Changzhi, Shanxi, China
        • Recruiting
        • Changzhi People's Hospital Affiliated to Changzhi Medical College
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with advanced gastric cancer confirmed by pathology or histology

Description

Inclusion Criteria:

  1. Age ≥18 years old, both male and female;
  2. patients with advanced gastric cancer diagnosed by pathology or histology and progressed or recurred after 6 months of adjuvant therapy can also be considered for enrollment;
  3. Have at least one measurable lesion on imaging (RECIST 1.1 criteria), the spiral CT or MR target lesion should be ≥10 mm and lymph node ≥15 mm;
  4. The investigator determines that the patient is amenable to treatment with karelizumab or apatinib;
  5. Voluntary enrollment; good compliance and willingness to cooperate with follow-up.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Previous use of other immunotherapy drugs (e.g. PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA4 monoclonal antibody, etc.);
  3. Prior use of other anti-angiogenic therapeutic agents (e.g., apatinib, etc.);
  4. Patients who, in the judgment of the investigator, are not suitable for inclusion.

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
cohort 1
First-line
Drug: Camrelizumab
200mg,iv,d1,Q2W/Q3W
Drug: apatinib
250mg,qd
Drug: chemotherapy
Standard treatment
cohort 2
Second-line
Drug: Camrelizumab
200mg,iv,d1,Q2W/Q3W
Drug: apatinib
250mg,qd
Drug: chemotherapy
Standard treatment
cohort 3
Third-line and above
Drug: Camrelizumab
200mg,iv,d1,Q2W/Q3W
Drug: apatinib
250mg,qd
Drug: chemotherapy
Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: 24 months
The percentage of subjects achieving complete or partial response in a real-world clinical setting.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 24 months
From date of admission until the date of first documented progression in the real-world setting or date of death from any cause, whichever came first, assessed up to 24 months.
24 months
Disease control rate
Time Frame: 24 months
The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting.
24 months
Overall survival
Time Frame: 24 months
From date of admission until the date of death from any cause, assessed up to 24 months.
24 months

Collaborators and Investigators

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

Sponsor

Changzhi People's Hospital Affiliated to Changzhi Medical College

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)

November 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastric cancer-RWS

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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