Esophageal Squamous Cell CancerPhase 1/2NCT01993784
Study of Nimotuzumab to Treat Esophageal Squamous Cell Carcinoma.
A Phase 1/2 study testing nimotuzumab in people with Esophageal Squamous Cell Cancer, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Cancer
- What is being tested?
- nimotuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Jun 2014
- Phase
- Phase 1/2
- 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
- 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)
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- 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 -
Who cannot join
- 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
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- Chronic diarrhea
- Mentally abnormal or disable cognition,including CNS metastasis
- Pregnancy or lactation period
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, MD, +86-10-88196561, lin100@medmail.com.cn
Lin Shen
About this study
Official title: Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas
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.
- Conditions
- Esophageal Squamous Cell Cancer
- Being tested
- nimotuzumab
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Nimotuzumab | Experimental | the nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression) Receives: Drug: nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
Measured: 6 weeks
Secondary outcomes (1)
adverse events
participants will be followed for the duration of hospital stay, an expected average of 1 week
Measured: during the treatment in the hosptital,an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD, Principal investigator, Peking Universtiy Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993784
- Sponsor's protocol ID
- ESCC-N-301
- Status last verified
- Nov 2013
- First submitted
- 16 Aug 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of Nimotuzumab in Second or Late- Line Treatment of Patients With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT01993784
- Acronym / sponsor ID
- ESCC-N-301
- Conditions
- Esophageal Squamous Cell Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab | Experimental | Drug: nimotuzumabthe nimotuzumab treatment: 2 levels (400 mg/w, 600 mg/w, weekly, until disease progression) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nimotuzumab | Drug | Nimotuzumab |
Primary outcome
Objective response rate
Time frame: 6 weeks
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
1 secondary outcome
adverse events
Time frame: during the treatment in the hosptital,an expected average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen, MD principal investigator
Peking Universtiy Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nimotuzumab in people with Esophageal Squamous Cell Cancer, run by Peking University 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Nov 2013. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihao Lu, MD (86-10-88196561, pppeirain@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2013.