Clinical Trial

A Phase I Study of SIM0388 in Participants With Malignant Ascites.

Name: A Phase I Study of SIM0388 in Participants With Malignant Ascites. — clinical trial record (NCT07007988)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: SIM0388-101

Recruiting Phase 1

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Summary

Malignant Ascites is a common complication of malignant tumor. The objective of this study is to evaluate the safety, efficacy, and pharmacokinetic characteristics of intraperitoneal perfusion with Docetaxel Polymeric Micelles (SIM0388) for injection in patients with malignant ascites

Trial Details

NCT Number	NCT07007988
Lead Sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Conditions	Malignant Ascites
Enrollment	50 participants
Start Date	2025-04-24
Primary Completion	2027-06 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2025-06-06