NCT02011594

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

December 7, 2013

Last Update Submit

February 11, 2015

Conditions

Stage IV Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • PFS (Progression free survival)

    12 months

Secondary Outcomes (3)

  • Objective Response Rate

    6 months

  • Overall survival (OS)

    12 months

  • Disease control rate (DCR)

    12 months

Study Arms (2)

Arm A

EXPERIMENTAL

Nimotuzumab

Drug: Nimotuzumab

Arm B

PLACEBO COMPARATOR

Placebo (normal saline)

Drug: Placebo

Interventions

NimotuzumabDRUG

400mg Q2W intravenously

Also known as: Anti epidermal growth factor receptor antibody h-R3
Arm A
PlaceboDRUG

Normal saline

Also known as: Normal saline
Arm B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Qiong Zhao

Hangzhou, Zhejiang, 310003, China

Location

The first affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

nimotuzumabSaline Solution

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Qiong Zhao, PhD

    First Affiliated Hospital,Zhejiang University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Thoracic Oncology

Study Record Dates

First Submitted

December 7, 2013

First Posted

December 13, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

CN(2)