Phase II Study of Intraperitoneal Injection of Serplulimab, Bevacizumab, and Recombinant Mutant Human Tumor Necrosis Factor for Treating Malignant Ascites After Standard Therapy Failure

What this Trial Is About

Malignant ascites, often arising from digestive system tumors with peritoneal metastases, is associated with poor prognosis and limited treatment options. Researchers are studying a combination of drugs including serplulimab a PD-1 inhibitor, bevacizumab, and recombinant mutant human tumor necrosis factor rmhTNF-NC to explore their effects on malignant ascites in patients who have not responded to standard therapies. This phase II clinical trial aims to evaluate the efficacy of these treatments administered locally into the abdominal cavity. Participants are assigned to one of three groups receiving different combinations serplulimab with bevacizumab serplulimab with rmhTNF-NC or serplulimab combined with both bevacizumab and rmhTNF-NC. The drugs are given via intraperitoneal injection on specific days, with serplulimab and bevacizumab administered on day 1 and day 15, while rmhTNF-NC is given on days 1, 4, 7, and 10. This approach targets the local tumor environment and malignant fluid buildup to assess potential benefits and interactions. During the study, participants will be monitored for responses in their malignant ascites over two months, including the objective response rate and control of ascites fluid. Other evaluations include duration of ascites relief up to one year, side effects, and changes in abdominal effusion symptoms. Assessments will involve clinical examinations, imaging, laboratory tests, and scoring of abdominal function. The trial involves regular follow-up to observe treatment effects and ensure safety throughout the participation period.

The Efficacy of Bevacizumab and Serplulimab Combined With Recombinant Mutant HumanTumor Necrosis Factor(rmhTNF-NC) in the Treatment of Malignant Ascites