Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368419

Enrollment

Registered

2011-06-08

Start date

2011-05-31

Completion date

2013-05-31

Last updated

2013-04-24

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

Conditions

Esophageal Cancer

Keywords

Endostar, Radiotherapy, Esophageal Cancer

Brief summary

This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.

Interventions

DRUGEndostar

75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks

RADIATIONRadiotherapy

6～15MV X-ray, 2Gy/time，5times/week，6 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer * Measurable disease according to RECIST criteria * ECOG Performance Status 0-1 * The length of esophageal carcinoma ≤ 10 cm * Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L * Renal function: Cr ≤ 2.0×UNL * Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL

Exclusion criteria

* Pregnant or lactating women * Evidence of bleeding diathesis, serious infection * Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) * Uncontrollable mental and nervous disorders

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR)	1 month after treatment

Secondary

Measure	Time frame
Overall Survival (OS)	2 years
Time to Progression (TTP)	every three months until disease progression
Clinical Benefit Rate (CBR)	1 month after treatment
Serum VEGF Levels	at baseline and 6 weeks
Incidence of Adverse Events	up to 3 months

Countries

China

Contacts

Primary ContactXiaodong Jiang, MD

86-0518-85605120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026