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Combination of Nimotuzumab,Capecitabine and Radiotherapy for Inoperable or Recurrent Gastric Cancer

NCT ID: NCT01180166

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-09-30

Brief Summary

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The prognosis of patients with inoperable locally advanced or residual/relapsed gastric cancer is rather poor. Concurrent capecitabine chemoradiotherapy is safe and recommended. Nimotuzumab, an anti-EGFR (epidermal growth factor receptor) monoclonal antibody, has shown its antitumor safety and efficiency in many phase I/II studies. Efficiency of combination of these treatment need to be further analyzed.

Detailed Description

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There is no standard treatment for patients with inoperable locally advanced or residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine chemoradiotherapy showed similar results. So far, more and more studies have shown that drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II studies. Because of poor survival of patients with inoperable locally advanced or residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine chemoradiotherapy need to be further analyzed.

Conditions

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Gastric Cancer Concurrent Chemoradiotherapy

Keywords

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Gastric cancer concurrent chemoradiotherapy target therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nimotuzumab

Combination of nimotuzumab and capecitabine concurrent chemoradiotherapy is received by patients.

Group Type EXPERIMENTAL

nimotuzumab

Intervention Type DRUG

200 milligram (mg) of nimotuzumab per week during radiation period

Interventions

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nimotuzumab

200 milligram (mg) of nimotuzumab per week during radiation period

Intervention Type DRUG

Other Intervention Names

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Nimotuzumab injection, Tai Xin-sheng

Eligibility Criteria

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Inclusion Criteria

* 18-75 years old, male or female
* Gastric cancer with measurable lesions, and the diameter is at least 1 cm
* Karnofsky score: at least 70
* Estimated survival: at least 6 months
* No prior target therapy or radiotherapy
* No severe hypertension, cardiac disease, or diabetes mellitus
* Normal blood routine and chemical tests
* Signed consent

Exclusion Criteria

* Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
* Extensive distant metastases
* Pregnancy or in lactation
* Allergic to 5-Fluorouracil
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Jing Jin, M.D.

vice chair of radiation department, Chinese Academy of Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jing jin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chinese Acedemy of Medical Sciences

Locations

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Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ningning Lu, Doctor

Role: CONTACT

Phone: +86 01087788280

Email: [email protected]

Jing Jin, M.D.

Role: CONTACT

Phone: +86 0108778280

Email: [email protected]

Facility Contacts

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Ningning Lu, Doctor

Role: primary

Jing Jin, M.D.

Role: backup

Other Identifiers

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CH-GI-010

Identifier Type: -

Identifier Source: org_study_id