Clinical Trial

Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy

Recruiting Phase 1/2
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Summary
This study is a prospective, multi-cohort Phase Ib/II clinical trial, consisting of two stages as follows: 1. Phase Ib Dose-Escalation Stage To explore the dose-limiting toxicities (DLT) of intraperitoneally administered liposomal irinotecan in patients with malignant peritoneal effusion who have failed prior standard therapy, and to estimate the maximum tolerated dose (MTD) of the investigational agent. 2. Phase II Expansion Stage To evaluate the efficacy and safety of liposomal irinotecan as monotherapy or in combination with recombinant modified human tumor necrosis factor or bevacizumab, in the treatment of malignant peritoneal effusion in patients who have failed prior standard therapy.
Trial Details
NCT Number NCT07397819
Lead Sponsor Dong sheng Zhang
Collaborators: CSPC Pharmaceutical Group Limited
Conditions Malignant Ascites
Enrollment 48 participants
Start Date 2025-11-28
Primary Completion 2028-06-30 (estimated)
Study Completion 2029-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-09