Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Sponsor

Biotech Pharmaceutical Co., Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT02591784

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

8.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal	Drug: Nimotuzumab Radiation: Radiotherapy	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nimotuzumab group Nimotuzumab+radiotherapy	Drug: Nimotuzumab the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks. Radiation: Radiotherapy the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)

Arm

Intervention/Treatment

Experimental: Nimotuzumab group

Nimotuzumab+radiotherapy

Drug: Nimotuzumab

the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.

Radiation: Radiotherapy

the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Complete response [3 months]
Partial response (PR) [3 months]
Stable disease (SD) [3 months]
Progressive disease (PD) [3 months]
Median survival time (MST) [2 years]
Overall survival (OS) [1 year,2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 .

Contacts and Locations

Locations

	Site	City	State	Country
1	The Affiliated tumour hosiptal of HARBIN Medical University	Harbin	Heilongjiang	China
2	Wuhan Union Hospital	Wuhan	Hubei	China
3	Qilu Hospital,Shandong University	Jinan	Shandong	China
4	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing		China
5	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China

Sponsors and Collaborators

Biotech Pharmaceutical Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biotech Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02591784

Other Study ID Numbers:

BT-IST-ESO-002

First Posted:

Oct 30, 2015

Last Update Posted:

Mar 17, 2022

Last Verified:

Aug 1, 2015

Keywords provided by Biotech Pharmaceutical Co., Ltd.

nimotuzumab esophageal radiotherapy

Additional relevant MeSH terms:

Esophageal Neoplasms

Nimotuzumab

Study Results

No Results Posted as of Mar 17, 2022