patients with digestive system tumors accompanied by peritoneal metastasis or ascites
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Pathologically diagnosed with gastrointestinal malignant tumor (except for liver malignancies, which may be clinically diagnosed); 2.Complete and reliable medical history and records; 3.Present with radiologically confirmed peritoneal metastasis or ascites; 4.Essentially normal laboratory results and examinations, including blood count, liver and kidney function, and electrocardiogram: Neutrophil count >= 1.5×10^?/L; Platelets >= 80×10^?/L; Hemoglobin >= 9.0 g/dL; Total bilirubin 50% at screening; 5.ECOG score 0–3, age >= 18 and <90 years, and able to undergo ascites/pleural fluid puncture and peripheral blood sampling; 6.Good compliance and willingness to undergo regular follow-up.
Exclusion criteria
Exclusion criteria: 1.Concurrent severe comorbidities: Active tuberculosis or severe infectious diseases; autoimmune or rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus); severe cardiac, pulmonary, hepatic, or renal insufficiency, or major cardiovascular diseases. 2.Non-malignant causes of pleural effusion/ascites: Including fluid accumulation due to heart failure, nephrotic syndrome, or cirrhosis. 3.?Pregnancy or lactation: Excluded due to potential effects of pregnancy on immune dynamics and biomarker fluctuations. 4.Prior antitumor therapy: Patients who deviated from standard regimens or received other experimental treatments, which may confound immune response assessments. 5.Contraindications/allergies: Hypersensitivity to procedures or agents used in the study. 6.?Psychiatric disorders: Severe mental illness or inability to comply with study requirements. 7.Other exclusions: Any condition deemed by investigators to compromise study integrity or patient safety.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR;Progress Free Survival,PFS;Overall Survival, OS; | — |
Primary
| Measure | Time frame |
|---|---|
| DCR; | — |
Countries
China
Contacts
zhejiang hospital