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

Last updated: June 26, 2024
Sponsor: Changzhi People's Hospital Affiliated to Changzhi Medical College
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

apatinib

chemotherapy

Camrelizumab

Clinical Study ID

NCT06485271
Gastric cancer-RWS
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years old, both male and female;

  2. patients with advanced gastric cancer diagnosed by pathology or histology andprogressed or recurred after 6 months of adjuvant therapy can also be considered forenrollment;

  3. Have at least one measurable lesion on imaging (RECIST 1.1 criteria), the spiral CTor MR target lesion should be ≥10 mm and lymph node ≥15 mm;

  4. The investigator determines that the patient is amenable to treatment withkarelizumab or apatinib;

  5. Voluntary enrollment; good compliance and willingness to cooperate with follow-up.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women;

  2. Previous use of other immunotherapy drugs (e.g. PD-1 monoclonal antibody, PD-L1monoclonal 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 Design

Total Participants: 504
Treatment Group(s): 3
Primary Treatment: apatinib
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Changzhi People's Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi
    China

    Active - Recruiting

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