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

NCT ID: NCT02579564

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Malignant Hydrothorax; Non Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Vinorelbine

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Pemetrexed

Intervention Type: DRUG

Oncorine

Intervention Type: DRUG

Endostar

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

Vinorelbine

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Pemetrexed

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Interventions

Gemcitabine

Intervention Type: DRUG

Vinorelbine

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Pemetrexed

Intervention Type: DRUG

Oncorine

Intervention Type: DRUG

Endostar

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Other Intervention Names

recombinant human adenovirus type 5 injection; recombinant human endostatin injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinqiao Hospital of Chongqing

OTHER

Sponsor Role: lead

Responsible Party

Zhengtang Chen

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ZhengTang Chen, PHD

Role: CONTACT

1240887467@qq.com

+862368755625

Other Identifiers

CTAEMTF

Identifier Type: -

Identifier Source: org_study_id