Stomach NeoplasmsPhase 2NIEGANCT03400592
Study of Nimotuzumab and Irinotecan as Second Line With Recurrent or Metastatic Gastric Adenocarcinoma
A Phase 2 study testing Irinotecan and nimotuzumab in people with Stomach Neoplasms, run by Peking University at 1 site in China.
Trial summary
The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Irinotecan and nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
- Willing to sign ICF
- Above 18 years
- KPS score≥70
- Expected survival time more than 90 days
- Subjects with EGFR overexpression (2+ or 3+ in IHC)
Show all 16Show fewer
- With target lesions in spiral CT or MRI examination within 30 days
- Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent ,platinum agent and Paclitaxel agent.
- Lab test of baseline meet following criteria
- Hemoglobin higher than 9.0g/dL
- Neutrophil higher than 1,500/mm3
- PLT higher than 10.0 104/mm3
- Bilirubin lower than 1.5 times of upper limit of normal range
- AST,ALT,ALP lower than 2.5 times of upper limit of normal range
- Creatinine lower than upper limit of normal range
- When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range
Who cannot join
- Patients who have received irinotecan
- Patients who are allergic to irinotecan or nimotuzumab.
- Other active malignancy within the last 5 years
- Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
- Investigator judge not eligible to this trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking cancer hospital
Beijing, Beijing Municipality, 100142
lin shen, MD. PhD, (86)10-88196561, linshenpku@163.com
jifang gong, MD. PhD, (86)10-88196561, gongjifang@gmail.com
About this study
Official title: Multi-center Phase II Trial of Nimotuzumab Plus Irinotecan in Patients With High EGFR Expression After Failure of First-line Treatment in Recurrent or Metastatic Gastric Adenocarcinoma（NIEGA）
The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.
Read the detailed description
The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.
- Conditions
- Stomach Neoplasms
- Being tested
- Irinotecan, nimotuzumab
- Keywords
- gastric adenocarcinoma, EGFR, Irinotecan, Nimotuzumab, biomarker
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
nimotuzumabDrug
400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
| Study group | Role | What they receive |
|---|---|---|
| irinotecan and nimotuzumab | Experimental | Administration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly Receives: Drug: Irinotecan; 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 by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (5)
Overall survival
Overall survival is defined as the time from the date of enrollment to the date of the death from any cause.
Measured: 3 years after first enrollment
Progression free survival
Progression Free Survival is defined as the time from the date of enrollment to the date of progression or death from any cause
Measured: 3 years after first enrollment
Disease control rate
Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Potential predictive biomarkers of nimotuzumab
Measured: 3 years after first enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study startJun 2015
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400592
- Sponsor's protocol ID
- NIEGA
- Acronym
- NIEGA
- Status last verified
- Jan 2018
- First submitted
- 10 Oct 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Phase II Trial of Nimotuzumab Plus Irinotecan in Patients With High EGFR Expression After Failure of First-line Treatment in Recurrent or Metastatic Gastric Adenocarcinoma（NIEGA）
- ClinicalTrials.gov ID
- NCT03400592
- Acronym / sponsor ID
- NIEGA / NIEGA
- Conditions
- Stomach Neoplasms
- Keywords
- gastric adenocarcinoma, EGFR, Irinotecan, Nimotuzumab, biomarker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 17 Jan 2018 (actual)
- 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.
The trial aims to evaluate the efficacy and safety of adding nimotuzumab to irinotecan after failure of first-line treatment in recurrent or metastatic gastric adenocarcinoma with overexpression of EGFR, and search for the effective biomarkers for nimotuzumab efficacy in gastric cancer.
Detailed description
The sample size was calculated using Simon's 2-stage design. The first stage require at least 4 or more out of 19 patients to have a confirmed partial or complete response (assuming P1 = 0.30, P0 = 0.10, with alpha = 0.05 and beta = 0.2) before proceeding to the second stage, in which additional 36 patients were needed. If a total of 15 or more patients achieve a confirmed objective response, then the primary end-point would have been met. The predicted response rate in this study is at least 30%. Blood and tissue samples are required to collect at baseline, response and disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| irinotecan and nimotuzumab | Experimental | Drug: Irinotecan, Drug: nimotuzumabAdministration of irinotecan 180 mg/m2 IV once every 2 weeks and nimotuzumab 400 mg IV once weekly |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Advanced unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma patients which meet the following criteria:
- Willing to sign ICF
- Above 18 years
- KPS score≥70
- Expected survival time more than 90 days
Key exclusion criteria (5 listed)
- Patients who have received irinotecan
- Patients who are allergic to irinotecan or nimotuzumab.
- Other active malignancy within the last 5 years
- Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
- Investigator judge not eligible to this trial
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 |
|---|---|---|
| Irinotecan180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient | Drug | irinotecan and nimotuzumab |
| nimotuzumab400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient | Drug | irinotecan and nimotuzumab |
Primary outcome
Objective response rate
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1.Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response
5 secondary outcomes
Overall survival
Time frame: 3 years after first enrollment
Progression free survival
Time frame: 3 years after first enrollment
Disease control rate
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Safety
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Potential predictive biomarkers of nimotuzumab
Time frame: 3 years after first enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan and nimotuzumab in people with Stomach Neoplasms, 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 16 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: status not confirmed, as of the sponsor's last update on 17 Jan 2018. 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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 17 Jan 2018.