late stage of NSCLC
Conditions
Interventions
local advanced (IIIB) or metastatic (IV) NSCLC:administration of gemcitabine with cisplatin chemotherapy plus endostar
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patients with locally advanced stage, pleural metastasis (IIIB period), distant metastasis (IV period) or unable to receive surgical resection, who primary proved non-small cell lung cancer by histology or cytological examination; 2. At least one measurable objective tumor lesions; the largest diameter of the tumor lesion should be >=1 cm with spiral CT or PET-CT examination, and its maximum diameter must be >=2 cm with common CT or MRI examination; 3. Life expectancy >=12 weeks; 4. Palliative radiotherapy only for the pain of the bone was allowed. Patients were permission to the group, who were ongoing of radiotherapy, post-operation and post radiotherapy for brain metastasis lesion; 5. 18 years of old or older.? ECOG physical status is 0 - 2; 6. Neutrophil cell count >=1.5*10^9/L, Platelet count >80*10^9/L; 7. Serum bilirubin must be <=1.5 times of the upper limits of normal (ULN); 8. AST, ALT <=2.5 times of the upper limits of normal (for liver metastases, AST, ALT<= 5 times of the upper limits of normal); 9. Serum creatinine <=1.5 times of the upper limits of normal; 10. To be able to follow the study and follow-up procedures; 11. The pregnancy test must be done within 72 hours before treatment and the results were negative for all the selected women who may be pregnant; 12. The patients have the potential must take effective contraceptive measures; 13. Sign the informed consent to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: 1. The NSCLC patients have received systemic chemotherapy; 2. undergoing excision, puncturatio or biopsy within seven days; 3. Any instability systemic diseases (including gastrointestinal ulcers, active infection, hypertension of grade four, unstable angina, congestive heart failure, metabolic disease of liver or kidney, bone fractures, the wound did not heal); 4. Concurrent use of anticoagulant drugs; 5. Obstacles of clotting mechanism, active bleeding and bleeding tendencies; 6. Suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell or squamous cell skin cancer; 7. Weight loses significantly, such as weight loss of 10% within six weeks; 8. Bone metastases as the only indicators were observed; 9. Hypersensitivity to preparations for E. coli; 10. Endostatin have been used; 11. breast-feeding women; 12. Clear statement that the taboo for gemcitabine, cisplatin or endotatin; 13. Current or planned in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Time to progression (TTP) and progresssion free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) of tumor; | — |
Countries
China
Contacts
Public ContactLu You
Outcome results
None listed