Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

Phase 2

• Conditions: Lung Cancer
• Interventions: Drug: Endostar; Drug: Docetaxel; Drug: Carboplatin; Drug: Pemetrexed

• Registration Number: NCT03706703
• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-01
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-15
• Study First Posted: 2018-10-16
• Last Update Posted: 2018-10-17
• Primary Completion: 2020-04-01
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Woman in pregnancy and breast-feeding, or having productive ability without contraception;

Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound;

Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension;

Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms;

Having the tendency of bleeding, such as FIB≤2G/L;

Being receiving adjuvant chemotherapy;

On other conditions investigator considers, the subject is not fitful to participate the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar continuous intravenous infusion	Docetaxel	Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
Endostar continuous intravenous infusion	Carboplatin	Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
Endostar continuous intravenous infusion	Pemetrexed	Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin
Endostar continuous intravenous infusion	Endostar	Endostar continuous intravenous infusion in combination with docetaxel/carboplatin or pemetrexed/carboplatin

Primary Outcome Measures

Name	Time	Method
ORR	8 weeks	objective response rate based on Recist 1.1 edition

Secondary Outcome Measures

Name	Time	Method
PFS	8 weeks	progress free survival

Trial Locations

Locations (1)

Affiliated Cancer Hospital & Institute of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China