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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01993784
Other study ID # ESCC-N-301
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received August 16, 2013
Last updated November 20, 2013
Start date August 2013
Est. completion date June 2014

Study information

Verified date November 2013
Source Peking University
Contact Zhihao Lu, MD
Phone 86-10-88196561
Email pppeirain@126.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 9
Est. completion date June 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
nimotuzumab


Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation 6 weeks No
Secondary adverse events participants will be followed for the duration of hospital stay, an expected average of 1 week during the treatment in the hosptital,an expected average of 1 week Yes
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