Endostar in Combination With Chemoradiotherapy in Patient With Advanced Non-small Cell Lung Cancer

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the safety and efficacy recombinant human endostatin(endostar) durative transfusion combined with cocurrent chemoradiotherapy in advanced non-small cell lung cancer(NSCLC).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of North Sichuan Medical College
• Collaborator: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Treatments: Cisplatin; Endostar protein; Endostatins; Etoposide

Criteria

Inclusion Criteria:

• 1. Male or female patients, age: 18-70 years of age

• 2. Pathology was diagnosed as non-small cell lung cancer. According to the Tumor Node Metastasis（TNM）stage of the 8th edition of the International Association for the Study of Lung Cancer in 2017, And the pathological stage was identified as stage IIIa-b.

• 3. No previous chest radiotherapy and radiotherapy, immunotherapy or biological therapy.

• 4. Eastern Cooperative Oncology Group (ECOG) test scored 0-1.

• 5. Serum hemoglobin ≥ 100g/L, platelet ≥ 100 × 109/L, absolute number of neutrophils ≥ 1.5 × 109/L.

• 6. Serum creatinine ≤ 1.25 times the upper limit of normal(UNL) or creatinine clearance ≥ 60 mL/min.

• 7. Serum bilirubin ≤ 1.5 times UNL, Aspartate aminotransferase (AST) and adenosine triphosphate (ALT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.

• 8. Forced vital capacity rate of one second（FEV1）>0.8 litre.

• 9. Coagulation function is normal

• 10. lesions are measurable according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST1.1)standard

• 11. Sign the inform consent form with good compliance

Exclusion Criteria:

• 1. Carcinoid or small cell lung cancer

• 2. Patients with any distant metastasis

• 3. patients with previous or current malignancy, except for skin non-melanoma or carcinoma in situ in the cervix

• 4. Any other disease or condition is a contraindication to chemoradiation (eg, active infection, 6 months after myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).

• 5. Pregnancy or breastfeeding women

• 6. Women who may be pregnant but are unwilling to take appropriate contraception

• 7. Hereditary bleeding or coagulopathy