advanced gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Have a diagnosis of gastric cancer confirmed by imaging, histopathology, or cytology, which is unresectable locally advanced or metastatic gastric cancer; 3.Baseline PHQ-9 score is greater than 5 at the beginning of immunotherapy; 4.Have at least one measurable lesion according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST); 5.Participants who have previously received or are currently receiving immunotherapy combined with standard chemotherapy; 6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1; 7. Laboratory test values must meet the following criteria within 7 days prior to the start of treatment: (1) Neutrophils >= 1.5 × 10^9/L; (2) Platelets >= 50 × 10^9/L; (3) Hemoglobin >= 90 g/L (no packed red blood cell transfusion within 2 weeks); (4) Serum albumin >= 30 g/L; (5) Serum creatinine = 50 mL/min; (6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 months; 9.Signed informed consent form;
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Previously treated with drugs targeting co-stimulatory or co-inhibitory T cell receptors (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) or CD137); 3. HER2-positive patients; 4. Other malignant tumors progressing within the past 3 years or requiring active treatment, except for basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ that have received potentially curative treatment (e.g., breast cancer, cervical carcinoma in situ); 5. Active autoimmune diseases requiring systemic treatment within the past 2 years; 6. Within 4 weeks before intervention, occurrence of grade 3 severe bleeding, severe non-healing wounds, ulcers, or fractures, or a history of esophageal or gastric variceal bleeding within 6 months; 7. Already undergone transplantation for solid tumors or hematologic malignancies; 8. Human immunodeficiency virus (HIV) infection; 9. Significant cardiovascular damage within 12 months after the first dose of study intervention, such as a history of congestive heart failure exceeding New York Heart Association (NYHA) class II, unstable angina, myocardial infarction or stroke, or arrhythmias associated with hemodynamic instability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The size of tumor;Depression score;Peripheral blood biochemical parameters, tumor markers, and neurotransmitter levels; | — |
Countries
China
Contacts
Drum Tower Hospital