Advanced Primary Lung Adenocarcinoma
Conditions
Keywords
endostar, CT Perfusion, Advanced Primary Lung Adenocarcinoma
Brief summary
To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window period.
Interventions
DRUGendostar
Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all.
Sponsors
Simcere Pharmaceutical Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically newly diagnosed as unresectable and metastasis advanced lung adenocarcinoma(Stage IV, Seventh Edition of the UICC/AJCC Classification for Lung Cancer). * At least one measurable objective tumor lesion, spiral CT or PET-CT examination: the shortest diameter ≥2cm，and no obvious necrosis * Life expectancy ≥12weeks * Patients receive palliative radiotherapy for bone's pain relief; patients receive radiotherapy for brain metastasis、patients after brain transfer operation or radiation therapy are allowed to enter the research. * 18≤Patients'age \<70 years. * Electrocolonogram (ECOG) Score:0-1. * Granulocyte count ≥ 2.0×109/L, platelet count ≥ 100×109/L. * Serum bilirubin within the normal range. * Aspartate aminotransferase ( AST ), Alanine aminotransferase ( ALT ) within the normal range(if the patients is diagonosed as liver metastasis,his/her AST/ALT should not surpass 1.5 times of the normal range ). * Serum creatinine within the normal range and creatinine clearance rate ≥60ml/min * Compliance with research requirements and be able to follow up. * Within 72 hours before the treatment, all women pregnant with pregnant possibility should undergo pregnancy test and get negative results. * Patients with fertility ability should take effective contraceptive techniques. * Sign informed consent of this clinic trial.
Exclusion criteria
* Lung adenocarcinoma patients who received systemic chemotherapy/thoracic radiotherapy/targeted therapy * Received resection, cutting or aspiration within seven days * Any unstable systemic diseases (including peptic ulcer、active infection、grade4 hypertension、unstable angina、congestive heart failure、liver, metabolic disorders or fracture、unhealing wound ) * Chronic kidney disease history(including chronic nephritis, nephrotic syndrome, Obstruction of urinary tract etc. caused by Urinary calculus) * have to use anticoagulant drugs at the same time * patients with obvious coagulation disorders、active bleeding and bleeding tendency * Any other malignancies (complete cure of cervical carcinoma in situ/basal cell carcinoma/squamous cell carcinoma are excluded )happened within 5 years. * Signifinant weight loss, weight lost during the 6 weeks more than or equal to 10% * Patients who take bone metastasis as the only observing index * Allergic to escherichia coli preparation * Used Endostar before * Lactating women * Contraindications written on Pemetrexed、Carboplatin、Dexamethasone instructions * Allergic to radiographic contrast agents * In the middle or planning to attend other clinic trails
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change of blood perfusion before/after the use of Endostar | per 3 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tumor to progress | 6 months | tumor to progress |
| clinical benefit rate | per 6 weeks | — |
| Adverse Drug Reaction | per 1 day | NCI-CTCAE V3.0 |
Countries
China
Contacts
Primary ContactYou Lu, MD
Backup ContactMeijuan Huang, MD
Outcome results
None listed