Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02579564|
Recruitment Status : Unknown
Verified October 2016 by Zhengtang Chen, Xinqiao Hospital of Chongqing.
Recruitment status was: Not yet recruiting
First Posted : October 19, 2015
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Hydrothorax Non Small Cell Lung Cancer||Drug: Gemcitabine Drug: Vinorelbine Drug: Paclitaxel Drug: Pemetrexed Drug: Oncorine Drug: Endostar Drug: Cisplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: chemotherapy with Oncorine and Endostar
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.
Other Name: recombinant human adenovirus type 5 injection
Other Name: recombinant human endostatin injection
Active Comparator: chemotherapy with cisplatin
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.
- Objective response rate (ORR) of malignant pleural effusions [ Time Frame: up to 3 years ]Assessed by WHO Cancerous effusion scoring system
- progression-free survival [ Time Frame: up to 3 years ]
- quality of life [ Time Frame: up to 3 years ]Assessed by Karnofsky Performance Status(KPS)
- side effects [ Time Frame: up to 3 years ]Assessed by NCI CTC3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579564
|Contact: ZhengTang Chen, PHDemail@example.com|