A Phase 3 interventional study of Gemcitabine and Vinorelbine in Malignant Hydrothorax and Non Small Cell Lung Cancer, sponsored by Xinqiao Hospital of Chongqing. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-21.
Sponsored by Xinqiao Hospital of Chongqing · Phase 3, Interventional, and Treatment
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 134 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Xinqiao Hospital of Chongqing is the lead sponsor of 68 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
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
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
Also known as: recombinant human adenovirus type 5 injection
Also known as: recombinant human endostatin injection
Objective response rate (ORR) of malignant pleural effusions
Assessed by WHO Cancerous effusion scoring system
Time frame: up to 3 years
progression-free survival
Time frame: up to 3 years
quality of life
Assessed by Karnofsky Performance Status(KPS)
Time frame: up to 3 years
side effects
Assessed by NCI CTC3.0
Time frame: up to 3 years
No study locations are listed for this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Xinqiao Hospital of Chongqing