Study of the safety and efficacy of brachytherapy (HB-001) by alpha-particle sources for malignant solid tumors

Not Applicable

• Conditions: Head and neck cancer or breast cancer

• Registration Number: JPRN-UMIN000036809
• Lead Sponsor: Hekabio K.K.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-25
• Study Completion: 2020-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in tumor size 10weeks after the HB-001 brachytherapy operation(RECIST1.1)

Secondary Outcome Measures

Name	Time	Method
Incidence, severity, and frequency of adverse events (AE) related to the device ECOG performance status