Not Yet RecruitingPhase 2

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

78 participantsStarted 2025-09-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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).
✓. Adequate coagulation function, defined as an International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN.

What they're measuring

ORR

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT07196540

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Dongsheng Zhang, Ph.D.

13719437860 zhangdsh@sysucc.org.cn

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