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Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

NCT02429726 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-04-29

No results posted yet for this study

Summary

Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, active controlled study.

Conditions

  • Malignant Pleural Effusion

Interventions

DRUG

rAdp53

Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion

DRUG

Cisplatin

Cisplatin will be administered by intra chest cavity infusion

DRUG

rAdp53 plus cisplatin

Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion

Sponsors & Collaborators

  • Shenzhen SiBiono GeneTech Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • China

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429726 on ClinicalTrials.gov