Esophageal
Conditions
Keywords
nimotuzumab esophageal radiotherapy
Brief summary
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 II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
Detailed description
Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
Interventions
DRUGNimotuzumab
the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.
RADIATIONRadiotherapy
the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)
Sponsors
Biotech Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis. 2. with the measureable lesion of the newly diagnosed the esophageal carcinoma. 3. age 18-75 years old 4. ECOG≤2 5. Expect survival date ≥3 months 6. without serious diseases of important organs 7. signature in the inform consent.
Exclusion criteria
1. pregnant or breast-feeding women or using a prohibited contraceptive method. 2. with psychiatric diseases. 3. with serious diseases or uncontrolled infection. 4. with history of other tumors. 5. participation other clinical trials within 1 month prior to inclusion in the trial. 6. not the first antitumor treatment .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.) | 3 months | assement of advers event after using medication based TAAE evaluation form |
Secondary
| Measure | Time frame |
|---|---|
| Partial response (PR) | 3 months |
| Stable disease (SD) | 3 months |
| Complete response | 3 months |
| Median survival time (MST) | 2 years |
| Overall survival (OS) | 1 year,2 years |
| Progressive disease (PD) | 3 months |
Countries
China
Outcome results
None listed