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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Drug: ENDOSTAR，cisplatin; Drug: Placebo , cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 290
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xiaoying Wang; Phone Number: 18201936643; Email: xiaoying.wang@simceregroup.com

Study Locations

• China
  • Shanghai, China
    • Xiaoying Wang
    • Contact: Xiaoying Wang; Phone Number: 18201936643; Email: xiaoying.wang@simceregroup.com
    • Principal Investigator: Shukui Qin, Doctor
    • Principal Investigator: Jin Li, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed cancer of any primary tumor type, Patients with Malignant Pleural Effusion or Ascites who remain poorly controlled after at least one systemic antitumor therapy and at least one local therapy (intracavitary administration of chemotherapeutic agents and/or biological response modulators, other than cisplatin.)
2. At least a medium amount of malignant pleural effusion or ascites conformed by confirmed by B ultrasound, Clinical judgment requires local therapy.
3. Karnofsky Performance Status ≥60
4. Life expectancy of at least 3 months
5. Adequate hematologic, cardiac, renal, and hepatic function
6. The serum pregnancy test of female subjects of childbearing age during the screening period was negative; With a fertile female/male subjects must be willing to throughout the study period (i.e., for the first time since the drug delivery to the end of the study drug dosing after 90 days) to take reliable contraceptive methods, including but not limited to: abstinence, male partners have accepted vasectomy, female sterilization, intrauterine device effectively and effective birth control pills.

Exclusion Criteria:

1. Participating in or receiving investigational treatment in another clinical trial within 4 weeks prior to first dosing, or participating in a device clinical trial within 4 weeks Evidence of bleeding diathesis, serious infection
2. Received systemic antitumor therapy or intraperitoneal drug therapy within 14 days of the first intracavitary administration;
3. Endostatin, bevacizumab, Ramucirumab, and other antiangiogenic agents or cisplatin were used for local therapy
4. Has not recovered from any adverse event due to any intervention to ≤1 prior to initial administration (except for hair loss, hearing loss, and neurological or endocrine disorders of ≤2 requiring alternative treatment)
5. Had undergone medium to major surgery other than diagnosis or biopsy within 28 days prior to first administration, or who were expected to undergo major surgery during the study period
6. Bilateral pleural effusion or enveloped pleural effusion or ascite
7. With severe COPD or a history of intestinal adhesions
8. uncontrolled primary brain tumor or central nerve metastatic tumor with significant intracranial hypertension or neuropsychiatric symptoms
9. Active infections that require systemic treatment
10. Pregnant or lactating women
11. history of illness, treatment, or laboratory abnormality that may interfere with the outcome of the study and prevent subjects from participating fully in the study, or participation is not considered by the investigator to be in the subjects' best interest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ENDOSTAR combined with cisplatin	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
Placebo Comparator: Placebo combined with cisplatin	Drug: Placebo , cisplatin; Placebo , cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture/drainage-Free Survival, PuFS	Compared with placebo combined with intracavitary cisplatin injection, use Puncture/drainage-Free Survival (Puncture/drainage-Free Survival, PuFS) as an indicator to evaluate Endo® combined with cisplatin intracavitary injection in the treatment of malignant pleural or ascites effusion Efficacy.	From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Shukui Qin, Doctor, Shanghai East Hospital of Tongji University; Study Chair: Jin Li, Doctor, Shanghai East Hospital of Tongji University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Cisplatin; Endostar protein
• Other Study ID Numbers: SIM-372-ENDO-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No