Overview

Endostar Durative Transfusion Combining With Gemcitabine-Cisplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

Status:
Unknown status
Trial end date:
2020-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether Endostar pumping into vein with Gemcitabine-Cisplatin are more effective than Endostar with Gemcitabine-Cisplatin regularly in the treatment of Non-Small Cell Lung Cancer (NSCLC).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Beijing Chest Hospital
Treatments:
Cisplatin
Endostar protein
Gemcitabine
Criteria
Inclusion Criteria:

1. Histologically or cytologically diagnosed NSCLC;

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

3. Age of 18-75years; 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.