Trial | NCT02591784  Report issue

Title

Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nimotuzumab ...

  • Study Participants

    42
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.
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.
Study Started
Nov 30
2008
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Mar 17
2022

Drug Nimotuzumab

the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.

Radiation Radiotherapy

the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)

Nimotuzumab group Experimental

Nimotuzumab+radiotherapy

Criteria 

Inclusion Criteria:

pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
with the measureable lesion of the newly diagnosed the esophageal carcinoma.
age 18-75 years old
ECOG≤2
Expect survival date ≥3 months
without serious diseases of important organs
signature in the inform consent.

Exclusion Criteria:

pregnant or breast-feeding women or using a prohibited contraceptive method.
with psychiatric diseases.
with serious diseases or uncontrolled infection.
with history of other tumors.
participation other clinical trials within 1 month prior to inclusion in the trial.
not the first antitumor treatment .
No Results Posted