NCT01993784

Brief Summary

Nimotuzumab 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 study assessed the safety and efficacy of different dosage of Nimotuzumab in second or late- line treatment of patients with locally advanced or metastatic esophageal squamous cell carcinomas.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

August 16, 2013

Last Update Submit

November 20, 2013

Conditions

Esophageal Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

    6 weeks

Secondary Outcomes (1)

  • adverse events

    during the treatment in the hosptital,an expected average of 1 week

Study Arms (1)

Nimotuzumab

EXPERIMENTAL

the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression)

Drug: nimotuzumab

Interventions

nimotuzumabDRUG
Nimotuzumab

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed esophageal squamous carcinoma,failed to first or second line chemothrepay
  • Age 18 to 75 years old
  • Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
  • Life expectancy of ≥3 month
  • Karnofsky performance status ≥80
  • WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
  • No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
  • Normal ECG/cardiac function
  • Good compliance
  • Having signed informed consent -

You may not qualify if:

  • No previous systemic therapy for metastatic esophageal squamous carcinoma
  • Known hypersensitivity to study drugs
  • Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
  • No measurable lesions, eg. pleural fluid and ascites
  • Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
  • Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
  • Chronic diarrhea
  • Mentally abnormal or disable cognition,including CNS metastasis
  • Pregnancy or lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

nimotuzumab

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

Study Officials

  • Lin Shen, MD

    Peking Universtiy Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihao Lu, MD

CONTACT

86-10-88196561pppeirain@126.com

Lin Shen, MD

CONTACT

86-10-88196561lin100@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Study Record Dates

First Submitted

August 16, 2013

First Posted

November 25, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

CN(1)