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 Phase 2 Interventional Study
Malignant Ascites
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Dong sheng Zhang · Other
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About This Trial
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 investigationa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Aged ≥18 years old, gender unrestricted. * Histologically or cytologically confirmed malignant peritoneal effusion derived from digestive system tumors (malignancy confirmed by ascites cytology, or peritoneal metastases diagnosed clinically based on imaging findings and sympto…
Contacts

Zhang Dongsheng

13719437860

zhangdsh@sysucc.org.cn

CONTACT

Wang Yingnan

15521145855

CONTACT