Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma
Primary Purpose
Stage IV Esophageal Squamous Cell Carcinoma
Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Esophageal Squamous Cell Carcinoma
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.
Sites / Locations
- Qiong Zhao
- The first affiliated hospital, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A
Arm B
Arm Description
Nimotuzumab
Placebo (normal saline)
Outcomes
Primary Outcome Measures
PFS (Progression free survival)
Secondary Outcome Measures
Objective Response Rate
Overall survival (OS)
Disease control rate (DCR)
Full Information
NCT ID
NCT02011594
First Posted
December 7, 2013
Last Updated
February 11, 2015
Sponsor
Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT02011594
Brief Title
Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma
Official Title
Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Withdrawn
Why Stopped
There was no participants enrolled in this clinical trial.
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Nimotuzumab
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline)
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Other Intervention Name(s)
Anti epidermal growth factor receptor antibody h-R3
Intervention Description
400mg Q2W intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
PFS (Progression free survival)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
6 months
Title
Overall survival (OS)
Time Frame
12 months
Title
Disease control rate (DCR)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiong Zhao, PhD
Organizational Affiliation
First Affiliated Hospital,Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qiong Zhao
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
The first affiliated hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Learn more about this trial
Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma
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