Nimotuzumab in Combination With Chemoradiation for Esopha... | NCT00950417

Studies
Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

NCT00950417

Sponsor

Biotech Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Aug 19, 2015Estimated

Enrollment

11Actual

Phase

Phase 1

Conditions

Advanced Esophageal

Interventions

Nimotuzumab

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jul 16, 2009

First Submission Date that Met QC Criteria

Jul 30, 2009

First Posted Date

Jul 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Label	Type	Description	Intervention Names
Esophageal Cancer	Experimental		Drug: Nimotuzumab

Name	Type	Description	Arm Group Labels	Other Names
Nimotuzumab	Drug		Esophageal Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.		within study period

Secondary Outcomes

Measure	Description	Time Frame
To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent form signed before performing any of the study's specific procedures.
ECOG performance status 0-2.
Age > 18 and < 75.
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
Histologically confirmed diagnosis of locally advanced esophageal.
Life expectancy of more than 3 months.
Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL

Exclusion Criteria:

Previous radiotherapy or chemotherapy
Pregnant or breast-feeding women
Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
Evidence of distant metastasis
Participation in other clinical trials
Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
Uncontrolled psychiatric disease or seizure
Patients not fit for the clinical trial judged by the investigators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xi-Chun Hu	Fu Dan University Cancer Hospital	Principal Investigator
Guo-Liang Jiang	Fu Dan University Cancer Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Cancer Hospital		Shanghai	Shanghai Municipality	200032	China