Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Cell Cancer
• Intervention / Treatment: Drug: nimotuzumab

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Peking University Cancer Hospital
      • Contact: Lin Shen, MD; Phone Number: +86-10-88196561; Email: lin100@medmail.com.cn
      • Principal Investigator: Lin Shen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nimotuzumab; the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)	Drug: nimotuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Lin Shen, MD, Peking Universtiy Cancer Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): November 25, 2013
• Last Update Submitted That Met QC Criteria: November 20, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Neoplasms, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: ESCC-N-301