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Recruiting NCT06485271

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

Observational Gastric Cancer RWS PD-1 Immunotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Camrelizumab, apatinib, chemotherapy.
Who it may be relevant to
Registry conditions: Gastric Cancer, RWS, PD-1 Immunotherapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • Drug Camrelizumab
    200mg,iv,d1,Q2W/Q3W
  • Drug apatinib
    250mg,qd
  • Drug chemotherapy
    Standard treatment

Primary outcome measures

  • Objective response rate [Time frame: 24 months]
Secondary outcome measures (3)
  • Progression free survival [Time frame: 24 months]
  • Disease control rate [Time frame: 24 months]
  • Overall survival [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years old, both male and female;
  • 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;
  • 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;
  • The investigator determines that the patient is amenable to treatment with karelizumab or apatinib;
  • Voluntary enrollment; good compliance and willingness to cooperate with follow-up.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Changzhi People's Hospital Affiliated to Changzhi Medical College — Changzhi

Identifiers

NCT: NCT06485271 · Gastric cancer-RWS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗