UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036809 |
|---|---|
| Receipt number | R000041765 |
| Scientific Title | Study of the safety and efficacy of brachytherapy (HB-001) by alpha-particle sources for refractory head & neck and breast cancer |
| Date of disclosure of the study information | 2019/05/25 |
| Last modified on | 2023/05/26 16:33:22 |
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Basic information
Public title
Study of the safety and efficacy of brachytherapy (HB-001) by alpha-particle sources for malignant solid tumors
Acronym
Clinical Study of HB-001 brachytherapy in Japan
Scientific Title
Study of the safety and efficacy of brachytherapy (HB-001) by alpha-particle sources for refractory head & neck and breast cancer
Scientific Title:Acronym
Clinical Study of HB-001 brachytherapy in Japan
Region
| Japan |
Condition
Condition
Head and neck cancer or breast cancer
Classification by specialty
| Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the HB-001 brachytherapy in patient with recurrent solid malignant cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction in tumor size 10weeks after the HB-001 brachytherapy operation(RECIST1.1)
Key secondary outcomes
Incidence, severity, and frequency of adverse events (AE) related to the device
ECOG performance status
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The HB-001 seeds are inserted into the tumor at an interval of up to 5 mm. The seeds are removed 14-22 days after the implantation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
>Head and neck cancer or breast cancer patients with histopathologically proven malignancies who have a history of radiation therapy and who have been diagnosed with refractory malignancies with or without medical treatment.
>Tumor size is 5 cm or less in the longest diameter
>Age 18 years or older
>ECOG performance status is 2 or less
0: Fully active, able to carry on all pre-disease performance without restriction
1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. E.g., light house work, office work
2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
>Life expectancy: 6 months or longer
>Vital signs (systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate) are stable
>Platelet count >= 100,000/mm3 and prothrombin time PT-INR <= 1.8
>WOCBP have to be confirmed not pregnant by a pregnancy test and have to agree to prevent conception throughout the study.
>Having received explanation about the study, consented to participate in the study and signed the informed consent form.
>Measurable disease according to RECIST v1.1
Key exclusion criteria
>The size of the tumor more than 5 cm in the maximum diameter.
>ECOG performance status is 3 or higher
3: Capable of only limited selfcare. Confined to bed or chair more than 50% of waking hours.
4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
>Continuously receiving medication that may have a significant impact on the evaluation of safety or efficacy, such as immunosuppressants and/or corticosteroids.
>History of serious allergy to the medicine for the treatments like anesthesia.
>There are tumors to be preferentially treated such as metastatic lesion other than the target tumor
>Having received chemotherapeutic drugs (except hormonal agents), immunotherapeutic agents, and molecular targeting agents in the past 30 days, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
>Having received immune checkpoint inhibitor in the past 2 months, which may affect the assessment of the safety or efficacy of the HB-001 brachytherapy.
>Having participated in different clinical studies in the past 30 days, which may affect the assessment of the safety or efficacy of HB-001 brachytherapy
>Pregnant women or breast-feeding mothers
>Those who do not wish to sign the informed consent form
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Shomoto |
Organization
Hekabio K.K.
Division name
R&D, Medical dev.&PV
Zip code
103-0027
Address
1-12-8 Nihonbashi, Chuo-ku Tokyo
TEL
03-6205-7585
koji.shomoto@hekabio.com
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Shomoto |
Organization
Hekabio K.K.
Division name
R&D, Medical dev.&PV
Zip code
103-0027
Address
1-12-8 Nihonbashi, Chuo-ku Tokyo
TEL
03-6205-7585
Homepage URL
HB-AT-001@hekabio.com
Sponsor or person
Institute
Hekabio K.K.
Institute
Department
Personal name
Funding Source
Organization
Hekabaio K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hekabio K.K.
Address
1-12-8 Nihonbashi, Chuo-ku Tokyo
Tel
03-6205-7585
koji.shomoto@hekabio.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立がん研究センター中央病院（東京都）、東京医科歯科大学医学部附属病院（東京都）、東北大学医学部（宮城）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
https://clinicaltrials.gov/ct2/show/NCT04906070
Publication of results
Published
Result
URL related to results and publications
https://clinicaltrials.gov/ct2/show/NCT04906070
Number of participants that the trial has enrolled
14
Results
Primary endpoint (efficacy)
Efficacy was evaluated in 11 of 10 head and neck cancer patients with a modified FAS response rate of 81.8% (95% CI: 48.2-97.7), significantly higher than the threshold response rate of 30%.
The response rate for three lesions was 66.7% (95% CI: 9.4-99.2), although the number of breast cancer patients could not be evaluated for efficacy because the target number of patients was not reached.
Results date posted
| 2023 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age at screening of the 14 patients was 72.6+/-10.24 years (mean +/- standard deviation, same below) and BMI was 22.16 +/- 3.588 kg/m2. There were 8 males (57.1%) and 6 females (42.9%). The breakdown of women was 3 cases each of head and neck cancer and breast cancer. ECOG PS ranged from 0 to 1 in all 14 patients.
Participant flow
1)Informed Consent
2)Screening (Confirmation of inclusion/exclusion criteria)
3)Implantation of investigational device (Day 0)
4)Removal of investigational device (Day 14)
5)Follow-up period (12 weeks)
6)End of trial
Adverse events
Secondary endpoints (safety)
Adverse events ;
Incidence of AEs associated with HB-001 was 100.0% (14/14 cases)
1 case of SAE (foreign body in the body: 7.1%)
Pain at the site of medical device use: 9 cases (64.3%)
Swelling at the site of medical device use: 7 cases (50.0%)
1 SAE unrelated to HB-001 (dysphagia: 7.1%)
Defects;
Defects: 18 in 5 cases
Accidental extractions: 7 cases
4 cases of clip detachment (including clip detachment)
3 cases of equipment dropout
2 cases of Sucher's detachment
1 each for disconnection and misalignment of equipment
Outcome measures
Primary Endpoint: Tumor size reduction at 10 weeks after insertion (based on RECIST guideline 1.1)
Secondary endpoint: Incidence, severity, and frequency of adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041765
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