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

NCT02579564 | Unknown Phase 3

• 1 other identifier: CTAEMTF
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Hydrothorax; Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) of malignant pleural effusions

  Assessed by WHO Cancerous effusion scoring system

  up to 3 years

Secondary Outcomes (1)

• progression-free survival

  up to 3 years

Other Outcomes (2)

• quality of life

  up to 3 years

• side effects

  up to 3 years

Study Arms (2)

chemotherapy with Oncorine and Endostar

EXPERIMENTAL

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; Drug: Endostar; Drug: Cisplatin

chemotherapy with cisplatin

ACTIVE COMPARATOR

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

Interventions

Gemcitabine DRUG

chemotherapy with Oncorine and Endostar; chemotherapy with cisplatin

Vinorelbine DRUG

chemotherapy with Oncorine and Endostar; chemotherapy with cisplatin

Paclitaxel DRUG

chemotherapy with Oncorine and Endostar; chemotherapy with cisplatin

Pemetrexed DRUG

chemotherapy with Oncorine and Endostar; chemotherapy with cisplatin

Oncorine DRUG

Also known as: recombinant human adenovirus type 5 injection

chemotherapy with Oncorine and Endostar

Endostar DRUG

Also known as: recombinant human endostatin injection

chemotherapy with Oncorine and Endostar

Cisplatin DRUG

chemotherapy with Oncorine and Endostar; chemotherapy with cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Vinorelbine; Paclitaxel; Pemetrexed; endostar protein; Endostatins; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

ZhengTang Chen, PHD

CONTACT

+862368755625; 1240887467@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 21, 2016

Record last verified: 2016-10