The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar

• Status: Unknown status
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Treatments: Endostar protein

Criteria

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