Systemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients

Sponsor

Xinqiao Hospital of Chongqing (Other)

Overall Status

Unknown status

CT.gov ID

NCT02579564

Collaborator

(none)

134

Enrollment

Arms

Duration (Months)

Study Details

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.

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

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Gemcitabine Drug: Vinorelbine Drug: Paclitaxel Drug: Pemetrexed Drug: Oncorine Other Names: recombinant human adenovirus type 5 injection Drug: Endostar Other Names: 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.	Drug: Gemcitabine Drug: Vinorelbine Drug: Paclitaxel Drug: Pemetrexed Drug: Cisplatin

Arm

Intervention/Treatment

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.

Drug: Gemcitabine

Drug: Vinorelbine

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Oncorine

Other Names:

recombinant human adenovirus type 5 injection

Drug: Endostar

Other Names:

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.

Drug: Gemcitabine

Drug: Vinorelbine

Drug: Paclitaxel

Drug: Pemetrexed

Drug: Cisplatin

Outcome Measures

Primary Outcome Measures

Objective response rate (ORR) of malignant pleural effusions [up to 3 years]
Assessed by WHO Cancerous effusion scoring system

Secondary Outcome Measures

progression-free survival [up to 3 years]

Other Outcome Measures

quality of life [up to 3 years]
Assessed by Karnofsky Performance Status(KPS)
side effects [up to 3 years]
Assessed by NCI CTC3.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.