None Small Cell Lung Cancer
Conditions
Interventions
1:human endostatin 7.5mg/m2 + Cisplatin 175mg/m2 +TP 80mg/m2 iv in day 1 and three weeks repeat and total two cycles
2:human endostatin 7.5mg/m2 for 14 days +TP 80mg/m2 iv in day 1 and + Cisplatin 175mg/m2 in day 5 five weeks repeat and total two cycles
3:TP 80mg/m2 iv in day 1 and + Cisplatin 175mg/m2 in day 5 five weeks repeat and total two cycles
Sponsors
Sichuan Province Luzhou Medical College affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of advanced NSCLC according to Histopathology and/or Cytology, with or without antitumor therapy; 2. At least 1 measurable tumor mass Previously first therapy (the tumor mass Diameter>=20mm by Chest radiography or CT or MRI scanning, Spira CT Diameter>=10mm); 3. Eastern Cooperative Oncology Group status 0-2; 4. Estimate Survival period>=3monthes; 5. Conform to Chemotherapy Indications and Basic requirements, for: Peripheral blood Almost normal, hart, liver and Kidney fanction. No obvious abnormality, ECG Almost normal. The body has no healing wounds; Laboratory indicators must meet the following requirements: Peripheral hemogram: White blood cell>=3.5*10^9 cells/L, Platelets>=80*10^9 cells/L, Hb>=90g/L. Renal function: Cr<=2.0UNL (upper limit of norma); Liver function: ALT <=1.5ULN; Total Bilirubin<=1.5ULN. If have liver metastases, ALT <=5ULN; Total Bilirubin<=2.5ULN; 6. Aged 18 to 75 years old; 7. At least after 4 weeks washout period, if have treated with other chemotherapy; 8. Be not hypersensitiveness with biologic agent,especially with genetic engineering agent of bacterium entericum; 9. The group participated in voluntary, previously signed informed consent, good compliance, can be matched with the experimental observation.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, in the period of duration but fails to take effective contraceptive measures; 2. Severe, uncontrolled infection; 3. Severe heart disease,include: backward heart failure, uncontrollable cardiac arrhythmia, unstable angina, myocardial infarction, Severe valvular heart disease and refractory hypertension; 4. There are uncontrollable nerves and mental disorder, or dysphrenia, bad compliance, that can not be matched with the experimental observation; primary cerebroma or uncontrolled metastatic tumor, with apparently intracranial hypertension or mental disorder; 5. At the same time using other experimental drugs or other clinical trials; 6. There are some other condition that investigator believe the patient is not suitable for the clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CTPI;determination of paclitaxel;determination of paclitaxel; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;MS; | — |
Countries
China
Contacts
Public ContactJuan Fan
Outcome results
None listed