Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

Multicenter Phase I/II Clinical Trial of Recombinant Human Endostatin Continued Pumping Into Vein Combining With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01733589

Enrollment

Registered

2012-11-27

Start date

2012-11-30

Completion date

2015-06-30

Last updated

2017-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III Non-small-Cell Lung Cancer

Keywords

Recombinant human endostatin, Non-small-Cell Lung Cancer, chemoradiotherapy

Brief summary

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently normalize the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

Detailed description

Primary Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC). Secondary Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients. Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

Interventions

DRUGRecombinant human endostatin

Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.

DRUGEtoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles

DRUGcisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles

OTHERlaboratory biomarker analysis

OTHERCT perfusion imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* untreated histologic or cytologic of NSCLC verified * inoperable stage IIIA or IIIB NSCLC * measurable disease by RECIST * 18\ 70 years of age * an ECOG PS of 0 to 1 * absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL * serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min * bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN * forced vital capacity in 1 second (FEV1) higher than 0.8 L * CB6 is normal * Written informed consent

Exclusion criteria

* a history of other malignant diseases * any contraindications for chemoradiotherapy * distant metastasis * malignant pleural and/or pericardial effusion * pregnant or nursing * preexisting bleeding diatheses or coagulopathy

Design outcomes

Primary

Measure	Time frame	Description
progression-free survival	2-year	from beginning treatment to progressive disease or the last follow-up

Secondary

Measure	Time frame	Description
treatment related toxicities	3 months	radiation-induced esophagitis; radiation-induced pneumonia
Response rate	1 month	complete response(CR); partial response(PR); stable disease(SD); progressive disease(PD)
overall survival	5 years	from date of beginning treatment until date of death

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026