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

NCT07196540 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Digestive System Neoplasms

Interventions

COMBINATION_PRODUCT

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

radiotherapy + rmhTNF-NC + tislelizumab

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-26
Primary Completion
2028-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07196540 on ClinicalTrials.gov