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

Sponsor
Dong sheng Zhang
Study ID
NCT07397819
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Malignant Ascites

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • liposomal irinotecan monotherapy — DRUG
    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
  • liposomal irinotecan monotherapy — DRUG
    Liposomal irinotecan (at RP2D, intraperitoneal injection \[ip\], administered on Day 1, Day 8, Day 15 and Day 21).
  • Liposomal Irinotecan + rmhTNF-NC — DRUG
    Liposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) rmhTNF-NC (300 IU per administration, ip, D1, D8, D15)
  • Liposomal Irinotecan + Bevacizumab — DRUG
    Liposomal Irinotecan (at RP2D dose, ip, D1, D8, D15, D21) Bevacizumab (100 mg, ip, D1, D15)

Study Details

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.

Key Dates

Start date
Nov 28, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib Dose-Escalation Stage
  • Experimental: Phase II Expansion Stage-ARM A
  • Experimental: Phase II Expansion Stage-ARM B
  • Experimental: Phase II Expansion Stage-ARM C

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 4 weeks after administration ]

Central Contacts

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