- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02011594
Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma
February 11, 2015 updated by: Qiong Zhao, Zhejiang University
Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital, Zhejiang University
-
Hangzhou, Zhejiang, China, 310003
- Qiong Zhao
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
Nimotuzumab
|
400mg Q2W intravenously
Other Names:
|
Placebo Comparator: Arm B
Placebo (normal saline)
|
Normal saline
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PFS (Progression free survival)
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival (OS)
Time Frame: 12 months
|
12 months
|
Objective Response Rate
Time Frame: 6 months
|
6 months
|
Disease control rate (DCR)
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Qiong Zhao, PhD, First Affiliated Hospital,Zhejiang University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
December 7, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 13, 2013
Study Record Updates
Last Update Posted (Estimate)
February 12, 2015
Last Update Submitted That Met QC Criteria
February 11, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Carcinoma
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Nimotuzumab
Other Study ID Numbers
- ZYTOP1407
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage IV Esophageal Squamous Cell Carcinoma
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Comprehensive Cancer NetworkCompletedGastric Adenocarcinoma | Recurrent Gastric Carcinoma | Esophageal Undifferentiated Carcinoma | Gastric Squamous Cell Carcinoma | Adenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer | Stage IV Esophageal Adenocarcinoma | Stage... and other conditionsUnited States
-
University of California, San FranciscoVarian Medical SystemsRecruitingStage IV Anal Cancer AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Postneoadjuvant Therapy Stage... and other conditionsUnited States
-
Fujian Medical University Union HospitalNot yet recruitingEsophageal Squamous Cell Carcinoma Thoracic Stage II | Esophageal Squamous Cell Carcinoma Thoracic Stage III | Esophageal Squamous Cell Carcinoma Thoracic Stage IVChina
-
National Cancer Institute (NCI)Active, not recruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Metastatic Malignant Neoplasm in the Brain and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingMetastatic Pancreatic Carcinoma | Stage IV Pancreatic Cancer AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Stage IV Colon Cancer AJCC v8 | Stage IV Rectal Cancer AJCC v8 | Stage IVA Colon Cancer AJCC v8 | Stage IVA Rectal Cancer AJCC v8 | Stage IVB Colon Cancer AJCC v8 | Stage IVB Rectal Cancer... and other conditionsUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH); National...Not yet recruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage II Esophageal Adenocarcinoma AJCC v8 | Clinical Stage II Esophageal Squamous Cell... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Gastric Squamous Cell Carcinoma | Gastroesophageal Junction Adenocarcinoma | Metastatic Malignant Neoplasm in the Stomach | Stage IV Esophageal Adenocarcinoma AJCC v7 | Stage IV Esophageal Squamous Cell Carcinoma AJCC v7United States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Zhejiang UniversityWithdrawnStage IV Esophageal Squamous Cell CarcinomaChina
-
The First Affiliated Hospital of Henan University...UnknownStage III Esophageal Squamous Cell Carcinoma | Stage II Esophageal Squamous Cell Carcinoma | Stage I Esophageal Adenocarcinoma | Stage II Esophageal Adenocarcinoma | Stage III Esophageal Adenocarcinoma | Stage I Esophageal Squamous Cell CarcinomaChina
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States