Gastric Cancer, PD-1 Immunotherapy, RWS
Conditions
Brief 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
Interventions
DRUGCamrelizumab
200mg,iv,d1,Q2W/Q3W
DRUGapatinib
250mg,qd
DRUGchemotherapy
Standard treatment
Sponsors
Changzhi People's Hospital Affiliated to Changzhi Medical College
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 24 months | The percentage of subjects achieving complete or partial response in a real-world clinical setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 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. |
| Disease control rate | 24 months | The percentage of subjects achieving complete response, partial response, or disease stability in a real-world clinical setting. |
| Overall survival | 24 months | From date of admission until the date of death from any cause, assessed up to 24 months. |
Countries
China
Outcome results
None listed