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.

Simcere

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Cisplatin; Drug: Gemcitabine; Drug: Endostar routine intravenous infusion; Drug: Endostar continuous intravenous infusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT02283476

SIM-ED-1302

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.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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. primary lung squamous carcinoma confirmed by cytology and histology, excluding sputum examination.
2. phase IIIB /IV based on IASLC 2009 TNM criteria.
3. at least one measurable tumor based on RECIST 1.1 ( longest diameter: ≥20 mm by CT scan or 10 mm by spiral CT )
4. male or female, age≥18 or ≤75 years old
5. ECOG PS: 0 or 1
6. estimated time of survival: ≥ 3 months
7. suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL
8. suitable liver function: Total bilirubin≤normal ULN, AST and ALT≤2.5×normal ULN, ALP≤5×normal ULN.
9. suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min
10. EKG normal
11. without no healing wound
12. no history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrolment.
13. for the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrolment.
14. no history of serious allergic to biologic agents, especially E.Coli products
15. the authorized ICF must be signed

Exclusion criteria

1. Woman in pregnancy and breast-feeding, or having productive ability without contraception.
2. Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound.
3. Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension.
4. 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.
5. Having the tendency of bleeding, such as FIB<2G/L
6. Being receiving adjuvant chemotherapy.
7. On other conditions investigator considers, the subject is not fitful to participate the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Endostar continuous intravenous infusion

Experimental group

Description:

Endostar continuous intravenous infusion in combination with Gemcitabine and Cisplatin

Treatment:

Drug: Endostar continuous intravenous infusion

Drug: Cisplatin

Drug: Gemcitabine

Endostar routine intravenous infusion

Active Comparator group

Description:

Endostar routine intravenous infusion in combination with Gemcitabine and Cisplatin

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: Endostar routine intravenous infusion