NCT07196540

IP rmhTNF-NC + Tislelizumab + Palliat RT for GIT Tumor Malignant Ascites After Failed Std Tx

A Prospective, Non-Randomized, Two-Cohort Clinical Study of Intraperitoneal Injection of Recombinant Modified Human Tumor Necrosis Factor Combined With Tislelizumab and Palliative Radiotherapy in the Treatment of Malignant Ascites From Digestive Tract Tumors After Failure of Previous Standard Treatments

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a prospective, dual-cohort clinical trial following a Simon two-stage design. Eligible subjects who met the inclusion criteria were enrolled. All participants were assigned to the following cohorts, consisting of patients with malignant ascites of the gastrointestinal tract confirmed by cytology or histology, who had experienced failure of prior standard therapy and required clinical intervention due to symptomatic disease. After providing signed informed consent and completing screening procedures, the patients received the following treatments: Cohort A (patients with large-volume abdominal metastatic lesions): Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab) Cohort B (patients without measurable abdominal metastatic lesions): Whole peritoneal cavity low-dose radiotherapy + intraperitoneal infusion (rmhTNF-NC + tislelizumab) All patients received only one treatment cycle. Objective efficacy was evaluated 4 weeks after treatment completion according to WHO criteria. Safety was assessed using NCI-CTCAE version 5.0. Subsequent treatments were not restricted by the study protocol, and clinicians could adjust the treatment plan based on the patient's specific condition.

Conditions

• Digestive System Neoplasms

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Radiotherapy for large-volume abdominal lesions + whole peritoneal cavity low-dose radiotherapy + rmhTNF-NC + tislelizumab	radiotherapy + rmhTNF-NC + tislelizumab

Timeline

• Start date: 2025-09-26
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2025-09-29
• Last updated: 2025-09-29