Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer

Esophageal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591784
• Other study ID #: BT-IST-ESO-002
• Status: Completed
• Phase: Phase 2
• Start date: November 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2015
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Esophageal
• Esophageal Neoplasms

Intervention

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)

Locations

Country	Name	City	State
China	Cancer Institute & Hospital, Chinese Academy of Medical Sciences	Beijing
China	The Affiliated tumour hosiptal of HARBIN Medical University	Harbin	Heilongjiang
China	Qilu Hospital,Shandong University	Jinan	Shandong
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)	assement of advers event after using medication based TAAE evaluation form	3 months
Secondary	Complete response		3 months
Secondary	Partial response (PR)		3 months
Secondary	Stable disease (SD)		3 months
Secondary	Progressive disease (PD)		3 months
Secondary	Median survival time (MST)		2 years
Secondary	Overall survival (OS)		1 year,2 years