Clinical trial NCT03706703: Rh-Endostatin (Endostar®) Continuous Intravenous Infusion
Official title: The Safety and Efficacy of Rh-Endostatin (Endostar®) Continuous Intravenous Infusion in Combination With Docetaxel/Carboplatin or Pemetrexed/Carboplatin (DC/PC) Regimens for Untreated Stage IIIB/IV Non-small-cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: ORR
timeFrame: 8 weeks
Secondary outcomes:
measure: PFS
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
state: Guangdong
Study officials:
References: