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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer; Malignant Hydrothorax
• Intervention / Treatment: Drug: Gemcitabine; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Vinorelbine; Drug: Oncorine; Drug: Endostar

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 Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ZhengTang Chen, PHD; Phone Number: +862368755625; Email: 1240887467@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age 18-75 yrs;
2. Kamofsky score (KPS) ≥70, and a predicted lifespan >3 months;
3. Enough function of vital organs, such as heart, liver and kidney;
4. Advanced NSCLC diagnosed by cytology or pathology
5. Unilateral or bilateral of malignant pleural effusion in the first time;
6. Patients who are considered as malignant pleural effusion by cytology or biomarkers (CEA, CA199, CA125) in pleural effusion;
7. Without systemic infection or high fever;
8. Without active EGFR mutation or unwilling to targeted molecular therapy;
9. 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.
10. No pleural cavity injection of antineoplastic drugs.

Exclusion Criteria:

1. Non-malignant pleural effusion;
2. Pleural effusion cause by other malignant tumors;
3. Allergic to Recombinant human adenovirus type 5 injection or Endostar;
4. Pregnant or lactation women;
5. Previously using Medicine for treating NSCLC with pleural cavity effusion by Systemic or pleural cavity perfusion treatment one month prior to enrollment;
6. Previously using the diuretics, albumin and anti-angiogenesis drugs, or dexamethasone one month prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Vinorelbine; Drug: Oncorine; Other Names: recombinant human adenovirus type 5 injection; Drug: Endostar; Other Names: 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.	Drug: Gemcitabine; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Vinorelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) of malignant pleural effusions	Assessed by WHO Cancerous effusion scoring system	up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	Assessed by Karnofsky Performance Status(KPS)	up to 3 years
side effects	Assessed by NCI CTC3.0	up to 3 years

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 20, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Hydrothorax; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Folic Acid Antagonists; Gemcitabine; Paclitaxel; Cisplatin; Vinorelbine; Pemetrexed; Endostar protein; Endostatins
• Other Study ID Numbers: CTAEMTF