AzTrials
AzTrials

Advanced EsophagealPhase 1NCT00950417

Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

A Phase 1 study testing Nimotuzumab in people with Advanced Esophageal, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Nimotuzumab (hR3) 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Esophageal
What is being tested?
Nimotuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteChina
Study dates
Jul 2009to Nov 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent form signed before performing any of the study's specific procedures.
  • ECOG performance status 0-2.
  • Age > 18 and < 75.
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
  • Histologically confirmed diagnosis of locally advanced esophageal.
  • Life expectancy of more than 3 months.
Show all 9Show fewer
  • Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
  • No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
  • Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL

Who cannot join

  • Previous radiotherapy or chemotherapy
  • Pregnant or breast-feeding women
  • Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
  • Evidence of distant metastasis
  • Participation in other clinical trials
  • Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
  • Uncontrolled psychiatric disease or seizure
  • Patients not fit for the clinical trial judged by the investigators

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer

Nimotuzumab (hR3) 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 phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.

Being tested
Nimotuzumab
Keywords
nimotuzumab esophageal chemo-radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NimotuzumabDrug

Study groups in NCT00950417
Study groupRoleWhat they receive
Esophageal CancerExperimentalNot described
Receives: Drug: Nimotuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.

    Measured: within study period

Secondary outcomes (1)

  1. To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2010
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00950417
Sponsor's protocol ID
BT-ESO-T-0901
Status last verified
Jul 2009
First submitted
16 Jul 2009
Last updated
19 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nimotuzumab in people with Advanced Esophageal, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. (time frame: within study period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00950417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in