This study is a prospective, non-randomized, dual-cohort Phase II clinical trial designed to explore the efficacy and safety of radiotherapy combined with intraperitoneal injection of Recombinant Mutant Human Tumor Necrosis Factor (rmhTNF-NC) and tislelizumab in the treatment of malignant ascites that has failed prior standard therapy.
After completing the informed consent process, eligible patients who meet the inclusion criteria will be enrolled. Participants will receive palliative radiotherapy combined with intraperitoneal perfusion of rmhTNF-NC and tislelizumab according to the study protocol. Before and after one cycle of treatment, abdominal ultrasound will be used to evaluate the response rate of ascites. Safety assessments will be conducted using NCI-CTCAE v5.0.
1. Age ≥ 18 years, regardless of gender. 2. Histologically or cytologically confirmed malignant ascites originating from digestive system tumors (confirmed by ascites cytology as malignant or clinically diagnosed as peritoneal metastases based on imaging and symptoms).
Peripheral blood count: WBC ≥ 4.0 × 10⁹/L, PLT ≥ 80 × 10⁹/L, Hb ≥ 90 g/L.
Renal function: Serum creatinine ≤ 2 × ULN and creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 ml/min.
Liver function: Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); or Total bilirubin > ULN but with direct bilirubin ≤ ULN; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (ALT or AST ≤ 5 × ULN allowed for patients with liver metastases).
1. History of allergy to original tumor necrosis factor (TNF), its derivatives, or tislelizumab.