Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients
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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
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
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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.
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Drug: Gemcitabine Drug: Vinorelbine Drug: Paclitaxel Drug: Pemetrexed Drug: Oncorine Other Name: recombinant human adenovirus type 5 injection Drug: Endostar Other Name: recombinant human endostatin injection Drug: Cisplatin |
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.
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Drug: Gemcitabine Drug: Vinorelbine Drug: Paclitaxel Drug: Pemetrexed Drug: Cisplatin |
- 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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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, PHD | +862368755625 | 1240887467@qq.com |
Responsible Party: | Zhengtang Chen, Chief Physician, Xinqiao Hospital of Chongqing |
ClinicalTrials.gov Identifier: | NCT02579564 |
Other Study ID Numbers: |
CTAEMTF |
First Posted: | October 19, 2015 Key Record Dates |
Last Update Posted: | October 21, 2016 |
Last Verified: | October 2016 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Hydrothorax Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Pleural Diseases Gemcitabine Paclitaxel Vinorelbine |
Cisplatin Pemetrexed Endostar protein Endostatins Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors |