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

Changzhi People's Hospital Affiliated to Changzhi Medical College

Status: Enrolling

Conditions: Gastric Cancer; RWS; PD-1 Immunotherapy

Treatments: Drug: Camrelizumab; Drug: chemotherapy; Drug: apatinib

Study type: Observational

Funder types: Other

Identifiers

NCT06485271

Gastric cancer-RWS

Details and patient eligibility

About

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

Enrollment: 504 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

504 participants in 3 patient groups

cohort 1

Description:

First-line

Treatment:

Drug: apatinib

Drug: chemotherapy

Drug: Camrelizumab

cohort 2

Description:

Second-line

Treatment:

Drug: apatinib

Drug: chemotherapy

Drug: Camrelizumab

cohort 3

Description:

Third-line and above

Treatment:

Drug: apatinib

Drug: chemotherapy

Drug: Camrelizumab