Nimotuzumab in Combination With Radiotherapy for Esophage... | NCT02591784

Studies
Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

NCT02591784

Sponsor

Biotech Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 17, 2022Actual

Enrollment

42Actual

Phase

Phase 2

Conditions

Esophageal

Interventions

Nimotuzumab
Radiotherapy

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

Aug 2015

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

Nov 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Aug 17, 2015

First Submission Date that Met QC Criteria

Oct 28, 2015

First Posted Date

Oct 30, 2015Estimated

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

Mar 3, 2022

Last Update Posted Date

Mar 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

Detailed Description

Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nimotuzumab group	Experimental	Nimotuzumab+radiotherapy	Drug: Nimotuzumab Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nimotuzumab	Drug	the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.	Nimotuzumab group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)	assement of advers event after using medication based TAAE evaluation form	3 months

Secondary Outcomes

Measure	Description	Time Frame
Complete response		3 months
Partial response (PR)		3 months
Stable disease (SD)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
with the measureable lesion of the newly diagnosed the esophageal carcinoma.
age 18-75 years old
ECOG≤2
Expect survival date ≥3 months
without serious diseases of important organs
signature in the inform consent.

Exclusion Criteria:

pregnant or breast-feeding women or using a prohibited contraceptive method.
with psychiatric diseases.
with serious diseases or uncontrolled infection.
with history of other tumors.
participation other clinical trials within 1 month prior to inclusion in the trial.
not the first antitumor treatment .

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
Lvhua Wang	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affiliated tumour hosiptal of HARBIN Medical University		Harbin	Heilongjiang		China
Wuhan Union Hospital

Intervention Browse Module

MeSH Terms

ID	Term
C501466	nimotuzumab
D011878	Radiotherapy

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided