Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer (NSCLC)

Fudan University

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Vinorelbine; Drug: Endostar; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01687439

NSCLC0901

Details and patient eligibility

About

Primary objective: functional imaging and quantitative imaging detection of the effects of Endostar combined with chemotherapy and radiotherapy on Non-small Cell Lung Cancer (NSCLC).

Secondary objective: To evaluate 1) the role of Endostar in regulating tumor vessels and normalizing of microenvironment; 2) Toxicity of Endostar combined with chemotherapy.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically proven inoperable stage IIIb-IV NSCLC
• ECOG PS 0-1
• Life expectancy > 3 months
• Adequate blood functions: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin ≥ 9 g / dL
• Adequate liver function: total bilirubin <1.5 times the upper limit of normal (ULN); AST and ALT <2.5 times ULN in patients without liver metastases, <5 times ULN in patients with liver metastases
• Adequate renal function: serum creatinine ≤ 1.25 times ULN or calculated creatinine clearance ≥ 50 mL / min and urinary protein <2+. In patients with baseline urinary protein ≥ 2+, 24 hours urine should be collected and 24 hours urine protein ≤ 1g
• International normalized ratio (INR) ≤ 1.5 and prothrombin time(PT) ≤ 1.5 times ULN within 7 days before enrollment
• Written informed consent

Exclusion criteria

• Evidence of bleeding diathesis or coagulopathy
• History of hemoptysis, defined as bright red blood more than half a teaspoon 3 months before enrollment
• Previously received chemotherapy and radiotherapy and biological targeted therapy
• Uncontrolled hypertension (systolic blood pressure> 150 mmHg and/or diastolic blood pressure> 100 mm Hg)
• Clinically significant (ie, active) cardiovascular diseases, such as cerebrovascular accident (within 6 months before initiating treatment), myocardial infarction (within 6 months before initiating treatment), unstable angina, congestive heart failure (New York Heart Association class ≥Grade II) , serious arrhythmia which needs medication during the study and may affect the study or can not be controlled by drugs
• Unhealed wounds, active peptic ulcer or fracture
• Gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before enrollment
• Women with intact uterus (menopause more than two years excluded) who are unwilling to take effective non-hormonal contraception (IUD, spermicide barrier birth control device or sterilization) during the study. Male who are unwilling to take effective contraceptive measures during the study
• Participated in other clinical trials within 28 days before the initiation of treatment.
• Allergic to any of the study drugs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Treatment

Experimental group

Description:

Eligible patients receive one cycle of Endostar monotherapy, two cycles of Endostar combined with chemotherapy (vinorelbine plus cisplatin) treatment, followed by Endostar plus radiotherapy treatment.

Treatment:

Drug: Cisplatin

Drug: Vinorelbine

Drug: Endostar

Radiation: Radiotherapy