Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain MetastasisPhase 2NCT06374888
Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases
A Phase 2 study testing Neratinib maleate in combination with capecitabine in people with Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis, run by Convalife (Shanghai) Co., Ltd..
Trial summary
To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
- What is being tested?
- Neratinib maleate in combination with capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Histologically or cytologically confirmed advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases (clear imaging evidence of metastasis)
- Tumor tissue was HER2 positive Her2-positive is defined as immunohistochemical (IHC) 3+ or IHC 2+ and in situhybridization (ISH) positive
- Presence of a measurable lesion according to RECIST 1.1: presence of at least one non-radiation-treated lesion with a diameter ≥10 mm (lymph node lesion with a diameter ≥15 mm) that can be accurately measured at baseline on CT or MRI and can be repeatedly measured. If study participants only have lesions after radiotherapy, and the lesions have been clearly identified as radiological progression and can be measured, they can be selected as target lesions. The brain lesion must have a measurable target lesion, but it is not required to have a measurable targetlesion outside the brain
- Corticosteroid dose did not increase one week before brain MRI examination
- There is no limit to previous treatment options, including chemotherapy, radiotherapy, targeted drugs, antibody coupling drugs, immunosuppressants, etc
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- Cohort A: Patients with brain metastases who have not previously received central nervous system radiotherapy should be more than 2 weeks from the end of the last systemic therapy. Patients who developed new brain lesions after craniotomy were allowed to be included if they had not received postoperative radiotherapy and were at least 2 weeks removed from surgery.
- Cohort B: Patients with disease progression or new lesions after whole brain radiotherapy or stereotactic radiotherapy; For lesions that have received local treatment, there is clear evidence of progress in imaging examination, and those that have received radiotherapy can be selected as target lesions. Patients with multiple central nervous system lesions, only one or a few of which received stereotactic radiotherapy, and those with lesions that did not receive local treatment, may still participate in the study
- Predicted survival ≥8 weeks
- Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period
- The patient can understand the situation of this study, and the patient and (or) legal representative voluntarily agree to participate in this trial and sign the informed consent
Who cannot join
- Participants who have received chemotherapy or radiation therapy (including study drugs) within 2 weeks prior to study participation, or who have not fully recovered from adverse events (excluding hair loss) due to taking drugs for more than 4 weeks
- Patients who have previously received anti-HER2 small-molecule TKI therapy progression
- More than two seizures in the first 4 weeks of enrollment
- Participants currently receiving any other study drug
- History of allergic reactions caused by compounds chemically or biologically similar to neratinib
- Concurrent use of enzyme-induced antiepileptic drugs (EIED), including phenytoin, carbamazepine, oxamazepine, phophenytoin, phenobarbital, pentobarbital, or primidone
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- Patients who were receiving any concurrent treatment for cancer during the study period, such as concurrent chemotherapy, radiation, or hormone therapy. Concurrent treatment with bisphosphonates is permitted, but should be started before the first dose of nelatinib
- Present with co-existing medical conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina, arrhythmia, or mental illness/social conditions that would limit compliance with study requirements
- Patients with known contraindications to MRI, such as pacemakers, shrapnel, or ocular foreign bodies
- Patients with pial metastasis only
- Severe malabsorption syndrome or inability to tolerate oral drugs
- Any chronic disease that causes diarrhea with CTCAE≥2 at baseline
- Women who are breastfeeding or whose blood or urine pregnancy test results are positive within 7 days before the first dosing of the study treatment
- The investigators identified patients with any conditions that compromised patient safety, interfered with study evaluation, or had poor adherence
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-arm, Open, Multicenter Phase II Clinical Study of Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases
To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis.
Read the detailed description
Twenty-eight patients with HER2-positive gastric cancer with brain metastasis were divided into two cohorts： Cohort A: Patients with brain metastases who have not previously received central nervous system radiotherapy, distance from the last systemic treatment junction The beam should be longer than 2 weeks. Cohort B: Patients with disease progression or new lesions after whole brain radiotherapy or stereotactic radiotherapy; For accepted offices For partially treated lesions, there is clear evidence of progress in imaging examination, and the lesions that have received radiotherapy can be selected as target diseases The kitchen range.
- Being tested
- Neratinib maleate in combination with capecitabine
- Keywords
- Her2-positive, esophageal, esophagogastric junction, gastric adenocarcinoma, brain metastasis
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neratinib maleate in combination with capecitabineDrug
Neratinib maleate tablets，Tablets, 40mg/ tablet, 180 tablets/bottle, orally, 240mg once daily, sealed, stored not above 25℃
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Cohort A: : Patients with brain metastases who had not previously received central nervous system radiotherapy, distance from the last systemic treatment junction The beam should be longer than 2 weeks. Cohort B: Patients with disease progression or new lesions after whole brain radiotherapy or stereotactic radiotherapy; For accepted offices For partially treated lesions, there is clear evidence of progress in imaging examination, and the lesions that have received radiotherapy can be selected as target diseases Receives: Drug: Neratinib maleate in combination with capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
Objective response rates: Proportion of patients whose tumor volume shrinks by 30% and is maintained for more than 4 weeks
Measured: Throughout the study for approximately 3.5 years
Secondary outcomes (6)
Central nervous response rate
reference to RANO-BM evaluation criteria for neurologic tumor brain metastases
Measured: Throughout the study for approximately 3.5 years
Objective response rates outside the central nervous system
ORR,Proportion of patients with a 30% reduction in tumor volume that lasts more than 4 weeks
Measured: Throughout the study for approximately 3.5 years
Disease control rate
It refers to the proportion of cases with complete response, partial response, and stable disease after treatment
Measured: Throughout the study for approximately 3.5 years
Duration of reaction
It refers to the time between the first evaluation of a tumor as CR or PR and the second evaluation as Progressive Disease (PD) or death from any cause.
Measured: Throughout the study for approximately 3.5 years
Clinical benefit rate
Refers to the time from the first evaluation of a tumor as CR or PR to the first evaluation as PD or death from any cause.
Measured: Throughout the study for approximately 3.5 years
overall survival
Refers to the time between the start of treatment and the patient's death or last follow-up.
Measured: Throughout the study for approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain MetastasisStudies of the same condition, open and under way.
- 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
- Model description
- Her2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374888
- Sponsor's protocol ID
- CVL009-2002
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Multicenter Phase II Clinical Study of Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases
- ClinicalTrials.gov ID
- NCT06374888
- Acronym / sponsor ID
- CVL009-2002
- Keywords
- Her2-positive, esophageal, esophagogastric junction, gastric adenocarcinoma, brain metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 19 Apr 2024 (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.
To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis.
Detailed description
Twenty-eight patients with HER2-positive gastric cancer with brain metastasis were divided into two cohorts： Cohort A: Patients with brain metastases who have not previously received central nervous system radiotherapy, distance from the last systemic treatment junction The beam should be longer than 2 weeks. Cohort B: Patients with disease progression or new lesions after whole brain radiotherapy or stereotactic radiotherapy; For accepted offices For partially treated lesions, there is clear evidence of progress in imaging examination, and the lesions that have received radiotherapy can be selected as target diseases The kitchen range.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Her2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Drug: Neratinib maleate in combination with capecitabineCohort A: : Patients with brain metastases who had not previously received central nervous system radiotherapy, distance from the last systemic treatment junction The beam should be longer than 2 weeks. Cohort B: Patients with disease progression or new lesions after whole brain radiotherapy or stereotactic radiotherapy; For accepted offices For partially treated lesions, there is clear evidence of progress in imaging examination, and the lesions that have received radiotherapy can be selected as target diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old
- Histologically or cytologically confirmed advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases (clear imaging evidence of metastasis)
- Tumor tissue was HER2 positive Her2-positive is defined as immunohistochemical (IHC) 3+ or IHC 2+ and in situhybridization (ISH) positive
- Presence of a measurable lesion according to RECIST 1.1: presence of at least one non-radiation-treated lesion with a diameter ≥10 mm (lymph node lesion with a diameter ≥15 mm) that can be accurately measured at baseline on CT or MRI and can be repeatedly measured. If study participants only have lesions after radiotherapy, and the lesions have been clearly identified as radiological progression and can be measured, they can be selected as target lesions. The brain lesion must have a measurable target lesion, but it is not required to have a measurable targetlesion outside the brain
- Corticosteroid dose did not increase one week before brain MRI examination
Key exclusion criteria (14 listed)
- Participants who have received chemotherapy or radiation therapy (including study drugs) within 2 weeks prior to study participation, or who have not fully recovered from adverse events (excluding hair loss) due to taking drugs for more than 4 weeks
- Patients who have previously received anti-HER2 small-molecule TKI therapy progression
- More than two seizures in the first 4 weeks of enrollment
- Participants currently receiving any other study drug
- History of allergic reactions caused by compounds chemically or biologically similar to neratinib
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 |
|---|---|---|
| Neratinib maleate in combination with capecitabineNeratinib maleate tablets，Tablets, 40mg/ tablet, 180 tablets/bottle, orally, 240mg once daily, sealed, stored not above 25℃ | Drug | Single-arm |
Primary outcome
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
Time frame: Throughout the study for approximately 3.5 years
Objective response rates: Proportion of patients whose tumor volume shrinks by 30% and is maintained for more than 4 weeks
6 secondary outcomes
Central nervous response rate
Time frame: Throughout the study for approximately 3.5 years
Objective response rates outside the central nervous system
Time frame: Throughout the study for approximately 3.5 years
Disease control rate
Time frame: Throughout the study for approximately 3.5 years
Duration of reaction
Time frame: Throughout the study for approximately 3.5 years
Clinical benefit rate
Time frame: Throughout the study for approximately 3.5 years
overall survival
Time frame: Throughout the study for approximately 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neratinib maleate in combination with capecitabine in people with Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis, run by Convalife (Shanghai) Co., Ltd..
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 11 inclusion and 14 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: opening soon, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaobing chen, ph.D (13937100233, zlyychenxb0807@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1 (time frame: Throughout the study for approximately 3.5 years). 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 19 Apr 2024.