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The Comparative Study on Rh-Endostatin (Endostar®) Continuous Intravenous Infusion and Routine i.v in Combination With GP Regimens for Phase III B/IV Squamous Cell Lung Cancer and Biological Markers Exploration.

NCT02283476 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-11-06

No results posted yet for this study

Summary

Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.The comparative study in efficacy and safety has not been done concerning continuous and routine i.v.In addition, what patient can be benefited from Endostar have not been investigated. The biological markers, such as circulating endothelial cells，CECs, will be explored in the study.

Conditions

Interventions

DRUG

Endostar continuous intravenous infusion

Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.

DRUG

Endostar routine intravenous infusion

Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total

DRUG

Gemcitabine

Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total

DRUG

Cisplatin

Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total

Sponsors & Collaborators

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT02283476 on ClinicalTrials.gov