Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

Esophageal Squamous Cell Cancer Clinical Trial

Official title:

Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01993784
• Other study ID #: ESCC-N-301
• 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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Cancer
• Neoplasms, Squamous Cell

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