NCT07397819

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

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：A Phase Ib/II Clinical Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Dong sheng Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Ascites

Interventions

Type	Name	Description
DRUG	liposomal irinotecan monotherapy	A "3+3" dose-escalation design will be adopted. A total of 9-18 eligible subjects will receive liposomal irinotecan treatment, with three predefined dose levels as follows: Dose Level 1: 20 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21. Dose Level 2: 30 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21. Dose Level 3: 40 mg, intraperitoneal injection (ip), administered on Day 1, Day 8, Day 15, and Day 21. Each subject will receive only one treatment cycle. The dosage of liposomal irinotecan will be escalated gradually from the lowest dose level to the highest. Dose-limiting toxicities (DLT) will be monitored throughout the administration cycle. Each subject will receive only one dose level of liposomal irinotecan during the study period. All subjects will complete the relevant tests specified in the protocol during treatment to evaluate safety and preliminary efficacy. Subsequent treatment regimens will be selecte
DRUG	liposomal irinotecan monotherapy	Liposomal irinotecan (at RP2D, intraperitoneal injection \[ip\], administered on Day 1, Day 8, Day 15 and Day 21).
DRUG	Liposomal Irinotecan + rmhTNF-NC	Liposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) rmhTNF-NC (300 IU per administration, ip, D1, D8, D15)
DRUG	Liposomal Irinotecan + Bevacizumab	Liposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) Bevacizumab (100 mg, ip, D1, D15)

Timeline

• Start date: 2025-11-28
• Primary completion: 2028-06-30
• Completion: 2029-06-30
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China