Stage IV Esophageal Squamous Cell CarcinomaPhase 2NCT02011594
Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma
A Phase 2 study testing Nimotuzumab in people with Stage IV Esophageal Squamous Cell Carcinoma, run by Zhejiang University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IV Esophageal Squamous Cell Carcinoma
- What is being tested?
- Nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2014to Feb 2015
- Phase
- Phase 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Qiong Zhao
Hangzhou, Zhejiang, 310003
The first affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: 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.
Read the detailed description
We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.
- Being tested
- Nimotuzumab, Placebo
- 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
Also called Anti epidermal growth factor receptor antibody h-R3
400mg Q2W intravenously
PlaceboDrug
Also called Normal saline
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Nimotuzumab Receives: Drug: Nimotuzumab |
| Arm B | Placebo comparator | Placebo (normal saline) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS (Progression free survival)
Measured: 12 months
Secondary outcomes (3)
Objective Response Rate
Measured: 6 months
Overall survival (OS)
Measured: 12 months
Disease control rate (DCR)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionFeb 2015
Why it stopped: There was no participants enrolled in this clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiong Zhao, Zhejiang University
- Investigators
- Qiong Zhao, PhD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011594
- Sponsor's protocol ID
- ZYTOP1407
- Status last verified
- Feb 2015
- First submitted
- 7 Dec 2013
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Maintenance Treatment of Nimotuzumab Versus No Maintenance for Advanced Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT02011594
- Acronym / sponsor ID
- ZYTOP1407
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There was no participants enrolled in this clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Dec 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.
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.
Detailed description
We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: NimotuzumabNimotuzumab |
| Arm B | Placebo comparator | Drug: PlaceboPlacebo (normal saline) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| NimotuzumabAlso: Anti epidermal growth factor receptor antibody h-R3400mg Q2W intravenously | Drug | Arm A |
| PlaceboAlso: Normal salineNormal saline | Drug | Arm B |
Primary outcome
PFS (Progression free survival)
Time frame: 12 months
3 secondary outcomes
Objective Response Rate
Time frame: 6 months
Overall survival (OS)
Time frame: 12 months
Disease control rate (DCR)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
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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.
Qiong Zhao, PhD principal investigator
First Affiliated Hospital of Zhejiang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab in people with Stage IV Esophageal Squamous Cell Carcinoma, run by Zhejiang University at 2 sites 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 8 inclusion and 5 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: withdrawn, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
PFS (Progression free survival) (time frame: 12 months). 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 12 Feb 2015.