RecruitingPhase 1/2

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

China48 participantsStarted 2025-11-28

Plain-language 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.

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 rate (calculated by the Cockcroft-Gault formula) ≥40 ml/min.
✓. Hepatic function: Total bilirubin ≤1.5×ULN; or total bilirubin \>ULN with direct bilirubin ≤ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (for patients with liver metastases, ALT or AST ≤5×ULN is acceptable).
✓. Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: 4 weeks after administration

Objective Response Rate

Timeframe: Up to 4 weeks after the first cycle

Trial details

NCT IDNCT07397819

SponsorDong sheng Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Zhang Dongsheng

13719437860 zhangdsh@sysucc.org.cn

View on ClinicalTrials.gov More Malignant Ascites trials