Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status and phase

Unknown

Phase 2

Conditions

Lung Cancer

Treatments

Drug: Pemetrexed

Drug: Endostar

Drug: Carboplatin

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT03706703

ENDOSTAR

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;

Phase IIIB/IV based on TNM criteria (8th);

At least one measurable tumor based on RECIST 1.1;

Without the known active mutation of EGFR/ALK/ROS1/RET;

Male or female, age≥18 or ≤70 years old;

ECOG PS: 0 or 1;

Estimated time of survival: ≥ 3 months;

Suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL;

Suitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN;

Suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min;

EKG normal;

Without healing wound;

No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment;

For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment;

No history of serious allergic to biologic agents, especially E.Coli products;

The authorized ICF must be signed.

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.