Changzhi People's Hospital Affiliated to Changzhi Medical College
Phase
Observational
Started
2023-11-01
Last updated
2024-07-03
Condition(s) studied
Gastric CancerRWSPD-1 Immunotherapy
Investigational drug(s) / intervention(s)
Camrelizumabapatinibchemotherapy
Camrelizumab: 200mg,iv,d1,Q2W/Q3W
apatinib: 250mg,qd
chemotherapy: Standard treatment
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
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
Objective response rate — 24 months The percentage of subjects achieving complete or partial response in a real-world clinical setting.
Trial sites (1)
Facility
City
Region
Status
Changzhi People's Hospital Affiliated to Changzhi Medical College
Changzhi
Shanxi
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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