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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinqiao Hospital of Chongqing
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Endostar protein; Endostatins; Gemcitabine; Paclitaxel; Pemetrexed; Vinorelbine

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.