Back to resultsSystemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients
Primary Purpose
Malignant Hydrothorax, Non Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gemcitabine
Vinorelbine
Paclitaxel
Pemetrexed
Oncorine
Endostar
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Hydrothorax
Eligibility Criteria
Inclusion Criteria:
- age 18-75 yrs;
- Kamofsky score (KPS) ≥70, and a predicted lifespan >3 months;
- Enough function of vital organs, such as heart, liver and kidney;
- Advanced NSCLC diagnosed by cytology or pathology
- Unilateral or bilateral of malignant pleural effusion in the first time;
- Patients who are considered as malignant pleural effusion by cytology or biomarkers (CEA, CA199, CA125) in pleural effusion;
- Without systemic infection or high fever;
- Without active EGFR mutation or unwilling to targeted molecular therapy;
- NO Anti tumor Radiotherapy chemotherapy and molecular targeted therapy,or Received Anti tumor Radiotherapy chemotherapy and molecular and clinical remission more than three months and in the past month ,disease progress with pleural cavity effusion but haven't use systemic or local anti tumor treatment.
- No pleural cavity injection of antineoplastic drugs.
Exclusion Criteria:
- Non-malignant pleural effusion;
- Pleural effusion cause by other malignant tumors;
- Allergic to Recombinant human adenovirus type 5 injection or Endostar;
- Pregnant or lactation women;
- Previously using Medicine for treating NSCLC with pleural cavity effusion by Systemic or pleural cavity perfusion treatment one month prior to enrollment;
- Previously using the diuretics, albumin and anti-angiogenesis drugs, or dexamethasone one month prior to enrollment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chemotherapy with Oncorine and Endostar
chemotherapy with cisplatin
Arm Description
Systemic chemotherapy with standard schemes, such as GP (Gemcitabine/Cisplatin), NP (Vinorelbine/Cisplatin), TP (Paclitaxel/Cisplatin) or PP (Pemetrexed/Cisplatin). Thoracic cavity perfusion of recombinant human adenovirus type 5 injection 1.5ml and Endostar 30mg each time, twice a week for four times.
Systemic chemotherapy with standard schemes without cisplatin, such as Gemcitabine, Vinorelbine, Paclitaxel or Pemetrexed. Thoracic cavity perfusion of cisplatin 30mg/m2 each time, twice a week for four times.
Outcomes
Primary Outcome Measures
Objective response rate (ORR) of malignant pleural effusions
Assessed by WHO Cancerous effusion scoring system
Secondary Outcome Measures
progression-free survival
Full Information
NCT ID
NCT02579564
First Posted
October 12, 2015
Last Updated
October 20, 2016
Sponsor
Xinqiao Hospital of Chongqing
1. Study Identification
Unique Protocol Identification Number
NCT02579564
Brief Title
Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients
Official Title
Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this multi-center clinical trial is to verify more effective on local control of malignant pleural effusions in NSCLC patients by thoracic cavity perfusion of recombinant human adenovirus type 5 injection and recombinant human Endostatin injection (Endostar) compared with cisplatin perfusion, with acceptable side effects.
Detailed Description
Malignant pleural effusion, which can malfunction of circulatory and respiratory systems, is a common complication in advanced NSCLC, finally decreases the quality of life and lifespan. Nowadays, it is still a challenge to effectively control malignant pleural effusion. In this multi-center randomized and controlled clinical trial, 134 NSCLC patients diagnosed as malignant pleural effusion in the first time will enroll. Based on systemic chemotherapy and pleural cavity perfusion, all eligible patients are randomly assigned into treatment group (recombinant human adenovirus type 5 and Endostatin injections) and control group (cisplatin) with ratio 1:1. Local control rate and side effects are record respectively. The anticipation is that treatment group obtains faster and longer control of pleural effusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Hydrothorax, Non Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy with Oncorine and Endostar
Arm Type
Experimental
Arm Description
Systemic chemotherapy with standard schemes, such as GP (Gemcitabine/Cisplatin), NP (Vinorelbine/Cisplatin), TP (Paclitaxel/Cisplatin) or PP (Pemetrexed/Cisplatin). Thoracic cavity perfusion of recombinant human adenovirus type 5 injection 1.5ml and Endostar 30mg each time, twice a week for four times.
Arm Title
chemotherapy with cisplatin
Arm Type
Active Comparator
Arm Description
Systemic chemotherapy with standard schemes without cisplatin, such as Gemcitabine, Vinorelbine, Paclitaxel or Pemetrexed. Thoracic cavity perfusion of cisplatin 30mg/m2 each time, twice a week for four times.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Vinorelbine
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Type
Drug
Intervention Name(s)
Oncorine
Other Intervention Name(s)
recombinant human adenovirus type 5 injection
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
recombinant human endostatin injection
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Primary Outcome Measure Information:
Title
Objective response rate (ORR) of malignant pleural effusions
Description
Assessed by WHO Cancerous effusion scoring system
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
up to 3 years
Other Pre-specified Outcome Measures:
Title
quality of life
Description
Assessed by Karnofsky Performance Status(KPS)
Time Frame
up to 3 years
Title
side effects
Description
Assessed by NCI CTC3.0
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-75 yrs;
Kamofsky score (KPS) ≥70, and a predicted lifespan >3 months;
Enough function of vital organs, such as heart, liver and kidney;
Advanced NSCLC diagnosed by cytology or pathology
Unilateral or bilateral of malignant pleural effusion in the first time;
Patients who are considered as malignant pleural effusion by cytology or biomarkers (CEA, CA199, CA125) in pleural effusion;
Without systemic infection or high fever;
Without active EGFR mutation or unwilling to targeted molecular therapy;
NO Anti tumor Radiotherapy chemotherapy and molecular targeted therapy,or Received Anti tumor Radiotherapy chemotherapy and molecular and clinical remission more than three months and in the past month ,disease progress with pleural cavity effusion but haven't use systemic or local anti tumor treatment.
No pleural cavity injection of antineoplastic drugs.
Exclusion Criteria:
Non-malignant pleural effusion;
Pleural effusion cause by other malignant tumors;
Allergic to Recombinant human adenovirus type 5 injection or Endostar;
Pregnant or lactation women;
Previously using Medicine for treating NSCLC with pleural cavity effusion by Systemic or pleural cavity perfusion treatment one month prior to enrollment;
Previously using the diuretics, albumin and anti-angiogenesis drugs, or dexamethasone one month prior to enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZhengTang Chen, PHD
Phone
+862368755625
Email
1240887467@qq.com
12. IPD Sharing Statement
Learn more about this trial
Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients
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