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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02579564
• Other study ID #: CTAEMTF
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 12, 2015
• Last updated: October 20, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Xinqiao Hospital of Chongqing
• Contact: ZhengTang Chen, PHD
• Phone: +862368755625
• Email: 1240887467[@]qq.com
• Is FDA regulated: No
• Health authority: China:Human Research Ethics Committee of Xinqiao Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 134
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Hydrothorax
• Lung Neoplasms
• Malignant Hydrothorax
• Non Small Cell Lung Cancer

Intervention

Drug:
• Gemcitabine

• Vinorelbine

• Paclitaxel

• Pemetrexed

• Oncorine

• Endostar

• Cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xinqiao Hospital of Chongqing

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	quality of life	Assessed by Karnofsky Performance Status(KPS)	up to 3 years	No
Other	side effects	Assessed by NCI CTC3.0	up to 3 years	No
Primary	Objective response rate (ORR) of malignant pleural effusions	Assessed by WHO Cancerous effusion scoring system	up to 3 years	No
Secondary	progression-free survival		up to 3 years	No