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
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion
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.
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
NCT ID
NCT04914598
First Posted
May 27, 2021
Last Updated
May 31, 2021
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
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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