Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma

NCT ID: NCT02011594

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-02-28

Brief Summary

There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.

Detailed Description

We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.

Conditions

Stage IV Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Nimotuzumab

Group Type: EXPERIMENTAL

Nimotuzumab

Intervention Type: DRUG

400mg Q2W intravenously

Arm B

Placebo (normal saline)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline

Interventions

Nimotuzumab

400mg Q2W intravenously

Intervention Type: DRUG

Placebo

Normal saline

Intervention Type: DRUG

Other Intervention Names

Anti epidermal growth factor receptor antibody h-R3; Normal saline

Eligibility Criteria

Inclusion Criteria

• Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.
• The sample size estimate: 20 cases per arm.
• Males or females aged ≥18 years, < 75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
• Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
• Adequate bone marrow, renal, and liver function are required.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
• Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• Allergy to anti-EGFR antibody.
• Female subjects should not be pregnant or breast-feeding.
• Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin < 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.
• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Qiong Zhao

Chief of Department of Thoracic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qiong Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital,Zhejiang University

Locations

Qiong Zhao

Hangzhou, Zhejiang, China

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

ZYTOP1407

Identifier Type: -

Identifier Source: org_study_id