Advanced Esophageal Clinical Trial
Official title:
Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer
Nimotuzumab (hR3) 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 phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.
| Status | Completed |
| Enrollment | 11 |
| Est. completion date | November 2012 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Informed consent form signed before performing any of the study's specific procedures. - ECOG performance status 0-2. - Age > 18 and < 75. - Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique. - Histologically confirmed diagnosis of locally advanced esophageal. - Life expectancy of more than 3 months. - Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy. - No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency - Neutrophils =3×109/L, platelet count=100×109/L and haemoglobin=9g/dL ,Creatinine = 1.5 x NUL Exclusion Criteria: - Previous radiotherapy or chemotherapy - Pregnant or breast-feeding women - Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection - Evidence of distant metastasis - Participation in other clinical trials - Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis - Uncontrolled psychiatric disease or seizure - Patients not fit for the clinical trial judged by the investigators |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Fudan University Cancer Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Biotech Pharmaceutical Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. | within study period | Yes | |
| Secondary | To determine the complete response rate?partial rate?disease responserate?disease control rate in the patients subject to treatment | 6 months | No |