Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

• Status: Unknown status
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hunan Province Tumor Hospital
• Treatments: Carboplatin; Endostar protein; Gemcitabine

Criteria

Inclusion Criteria:

1. Histologically or cytologically diagnosed NSCLC;

2. primary treatment,inoperable stage III/IV NSCLC;

3. Age of 18-70years; Gender Not Required;

4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:

liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function:

S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10^9/l, ANC≥2.0×10^9/l platelet count ≥100×10^9/l, Hb≥100 g/l;

5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;

6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);

7. No history of serious drug allergy;

8. Informed consent should be obtained before treatment.

Exclusion Criteria:

1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;

2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);

3. Serious complications and investigator consider it is unsuited enrolling;

4. Pregnant or lactating women;

5. Allergic to research drug;

6. participating in other experimental trials and receive the treatment in four weeks;

7. The position that is for observing curative effect have a radiotherapy.