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Status unknownNCT01368419Updated Apr 24, 2013

Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

A Phase 2 interventional study of Endostar and Radiotherapy in Esophageal Cancer, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-04-24.

Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Esophageal Cancer

Keywords

  • Endostar
  • Radiotherapy
  • Esophageal Cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 40 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Treatment

    Drug: Endostar · Radiation: Radiotherapy

Interventions

  • DrugEndostar

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

  • RadiationRadiotherapy

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

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 1 month after treatment

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 2 years

  2. Time to Progression (TTP)

    Time frame: every three months until disease progression

  3. Clinical Benefit Rate (CBR)

    Time frame: 1 month after treatment

  4. Serum VEGF Levels

    Time frame: at baseline and 6 weeks

  5. Incidence of Adverse Events

    Time frame: up to 3 months

07

Study locations

1 of 1 sites recruiting
  • The First People's Hospital of Lianyungang
    Lianyungang, Jiangsu 222002, China
    • Xiaodong Jiang, MD · Contact · 0518-85605120
    • Xiaodong Jiang, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01368419
Lead sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators
The First People's Hospital of Lianyungang
Responsible party
Sponsor
First posted
Jun 8, 2011
Start date
May 2011
Primary completion
May 2013 (estimated)
Completion
May 2013 (estimated)
Last update
Apr 24, 2013

Study contacts

Xiaodong Jiang, MD
Contact
86-0518-85605120
Xiaodong Jiang, MD
principal investigator · The First People's Hospital of Lianyungang

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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