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Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

NCT ID: NCT01993784

Last Updated: 2013-11-25

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

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-06-30

Brief Summary

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Nimotuzumab 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 study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.

Detailed Description

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Conditions

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Esophageal Squamous Cell Cancer

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

the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)

Group Type EXPERIMENTAL

nimotuzumab

Intervention Type DRUG

Interventions

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nimotuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed esophageal squamous carcinoma,failed to first or second line chemothrepay
* Age 18 to 75 years old
* Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
* Life expectancy of ≥3 month
* Karnofsky performance status ≥80
* WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
* Normal ECG/cardiac function
* Good compliance
* Having signed informed consent -

Exclusion Criteria

* No previous systemic therapy for metastatic esophageal squamous carcinoma
* Known hypersensitivity to study drugs
* Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
* Pregnancy or lactation period
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Shen Lin

Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lin Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Universtiy Cancer Hospital

Locations

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Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihao Lu, MD

Role: CONTACT

Phone: 86-10-88196561

Email: [email protected]

Lin Shen, MD

Role: CONTACT

Phone: 86-10-88196561

Email: [email protected]

Facility Contacts

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Lin Shen, MD

Role: primary

Other Identifiers

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ESCC-N-301

Identifier Type: -

Identifier Source: org_study_id