Head and neck cancer or breast cancer
Conditions
Interventions
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
Sponsors
Hekabio K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in tumor size 10weeks after the HB-001 brachytherapy operation(RECIST1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, severity, and frequency of adverse events (AE) related to the device ECOG performance status | — |
Countries
Japan
Contacts
Public ContactKoji Shomoto
Hekabio K.K. R&D, Medical dev.&PV
Outcome results
None listed