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

Primary Purpose

Malignant Pleural Effusion

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ENDOSTAR,cisplatin
Placebo , cisplatin
Sponsored by
Jiangsu Simcere Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiaoying Wang

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ENDOSTAR combined with cisplatin

Placebo combined with cisplatin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2021
Last Updated
May 31, 2021
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04914598
Brief Title
A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ENDOSTAR combined with cisplatin
Arm Type
Active Comparator
Arm Title
Placebo combined with cisplatin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ENDOSTAR,cisplatin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo , cisplatin
Intervention Description
Placebo , cisplatin
Primary Outcome Measure Information:
Title
Puncture/drainage-Free Survival, PuFS
Description
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.
Time Frame
From the date of the end of experiment therapy to the next Puncture /drainage or death from any cause, up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) At least a medium amount of malignant pleural effusion or ascites conformed by confirmed by B ultrasound, Clinical judgment requires local therapy. Karnofsky Performance Status ≥60 Life expectancy of at least 3 months Adequate hematologic, cardiac, renal, and hepatic function 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: 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 Received systemic antitumor therapy or intraperitoneal drug therapy within 14 days of the first intracavitary administration; Endostatin, bevacizumab, Ramucirumab, and other antiangiogenic agents or cisplatin were used for local therapy 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) 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 Bilateral pleural effusion or enveloped pleural effusion or ascite With severe COPD or a history of intestinal adhesions uncontrolled primary brain tumor or central nerve metastatic tumor with significant intracranial hypertension or neuropsychiatric symptoms Active infections that require systemic treatment Pregnant or lactating women 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoying Wang
Phone
18201936643
Email
xiaoying.wang@simceregroup.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shukui Qin, Doctor
Organizational Affiliation
Shanghai East Hospital of Tongji University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jin Li, Doctor
Organizational Affiliation
Shanghai East Hospital of Tongji University
Official's Role
Study Chair
Facility Information:
Facility Name
Xiaoying Wang
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoying Wang
Phone
18201936643
Email
xiaoying.wang@simceregroup.com
First Name & Middle Initial & Last Name & Degree
Shukui Qin, doctor
First Name & Middle Initial & Last Name & Degree
Jin Li, doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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