Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

NCT00950417 | Completed Phase 1 DMC

• 1 other identifier: BT-ESO-T-0901
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Advanced Esophageal

Keywords

nimotuzumab esophageal chemo-radiotherapy

Outcome Measures

Primary Outcomes (1)

• Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

  within study period

Secondary Outcomes (1)

• To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment

  6 months

Study Arms (1)

Esophageal Cancer

EXPERIMENTAL

Drug: Nimotuzumab

Interventions

Nimotuzumab DRUG

Esophageal Cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

nimotuzumab

Study Officials

• Xi-Chun Hu

  Fu Dan University Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Guo-Liang Jiang

  Fu Dan University Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 31, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2012
• Last Updated: August 19, 2015

Record last verified: 2009-07

Locations

CN (1)