NCT04914598

A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions

A Randomized, Controlled, Double-blind, Multi-center Phase Ⅲ Registration Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Malignant Pleural Effusion or Ascites is a common complication of malignant tumor, The objective of this study is to compare the efficacy of Endostar/cisplatin with placebo/cisplatin in patients with malignant pleural effusion or ascites.

Conditions

• Malignant Pleural Effusion

Interventions

Type	Name	Description
DRUG	ENDOSTAR，cisplatin	After sufficient puncture and drainage or drainage, use Endo® (45mg/time in thoracic cavity, 60mg/time in abdominal cavity) + cisplatin (40mg/time) intracavitary injection, administration on 1, 4, and 7 days, 3 times as a course of treatment
DRUG	Placebo , cisplatin	Placebo , cisplatin

Timeline

• Start date: 2021-07-28
• Primary completion: 2025-02-10
• Completion: 2026-06-01
• First posted: 2021-06-04
• Last updated: 2026-01-02

Locations

1 site across 1 country: China