gastric cancer
Conditions
Interventions
Immunotherapy combined with radiotherapy:1.Immune checkpoint inhibitor therapy, administered every 3 weeks, with dosing based on the recommended dosage in the instructions for use. The medications use
Sponsors
Jinan central hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed Stage IV or recurrent gastric cancer or gastroesophageal junction adenocarcinoma, with failure of at least one line of platinum-containing chemotherapy. 2. Planned to receive palliative radiotherapy to the metastatic or primary site, with a required total radiation dose of EQD2 >= 30 Gy. 3. Known results of Her2 and programmed death ligand 1 (PD-L1) expression levels. 4. Age between 18 and 80 years. 5. Estimated survival of >= 3 months, and an ECOG performance status score of 0 or 1. 6. Presence of measurable disease as defined by the investigator according to RECIST v1.1. 7. Organ function levels must meet the following requirements without transfusion, use of any hematopoietic growth factors, and/or platelet-increasing medications within 14 days prior to screening, and must meet the following criteria: (1) Hematologic function: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, hemoglobin>= 90 g/L; (2)Liver function: Total bilirubin (TBIL) = 50 mL/min (according to the Cockcroft and Gault formula); (4) Coagulation function: International normalized ratio (INR)<=1.5, and activated partial thromboplastin time (APTT) <= 1.5 × ULN. 8. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous exposure to immunotherapy with Grade 3 or higher immune-related adverse events (irAEs), and deemed by the physician as unsuitable for further immunotherapy, or presence of contraindications to immunotherapy. 2. Participants with known active central nervous system metastases and/or carcinomatous meningitis. 3. Received radiotherapy or systemic anti-tumor treatment within 14 days prior to the first dose of study treatment. 4. Presence of active infections, as well as ulcerated or unhealed wounds. 5. Patients with large amounts of pleural or peritoneal effusion, or symptomatic pleural or peritoneal effusion, or poorly controlled pleural or peritoneal effusion. 6. Positive for human immunodeficiency virus antibody (HIVAb), active hepatitis B virus infection (HBsAg positive with HBV-DNA > 10^3 copies/ml), or hepatitis C virus infection. 7. Uncontrolled severe cardiovascular and cerebrovascular diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactMeili Sun
Jinan central hospital
Outcome results
None listed