Study of Concurrent Chemo-radiotherapy Combined With Recombinant Human Endostatin for Local Advanced Non-small Cell Lung Cancer (NSCLC)

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

It is a trials to evaluate the overall survival (OS) of radiotherapy / EP combined with recombinant human endostatin in treatment of locally advanced (Ⅲ A / unresectable Ⅲ B) non-small cell lung cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Simcere Pharmaceutical Co., Ltd
• Collaborator: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Treatments: Endostatins

Criteria

Inclusion Criteria:

1. Patients with pathologically or histologically confirmed and inoperable stage Ⅲ (Ⅲ A or unresectable Ⅲ B) NSCLC;

2. Patients with ages of 18~70 years, general condition ECOG performance scale （PS）≤ 1, weight loss <10% during last 6 months;

3. CT films of patients during last 4 weeks were accessible when patients were selected into the groups, the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, PET-CT, with the largest diameter≥ 20mm by ordinary CT and MRI.）

4. No major organ dysfunction, the function of heart, liver and kidney was normal, laboratory indicators should meet the following requirements: Blood: WBC> 4.0 × 109 / L, absolute neutrophil count > 1.5 × 109 / L, platelet count> 100 × 109 / L, hemoglobin> 110g / L; liver function: serum bilirubin was less than 1.5 × maximum normal value ; ALT and AST were less than 1.5 × maximum normal value; BUN, Cr within the normal range; FEV1 > 1L or> 40% of predicted value;

5. Patients could understand the circumstances of this study and those who have signed the informed consent form;

Exclusion Criteria:

1. Pregnant or lactating women; women of child-bearing age without contraception;

2. Acute infection or other serious underlying diseases;

3. Significant neurological, psychiatric history, including dementia which may influence the ability to understand and the informed consent;

4. Receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs a the same time; have joined other drug clinical trials 30 days before this clinical trial;

5. Diabetes without control (blood-glucose is unstable or ≥ 8mol / L after administration);

6. Patients who are allergic to E. coli preparation;

7. Patients who are unsuitable to participate in this trial determined by the researchers.