Clinical trial · Interventional
A Study About the Operation Efficacy and the Early Stage Safety of Heavy Ion Beam Treatment System in Solid Tumor
NCT05764486CI-TRIAL-00064594completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to investigate the safety of Hitachi's Heavy Ion Beam Therapy System HyBEAT for treating patients with solid tumor in Taipei Veterans General Hospital, including patients early-stage adverse reactions and the efficacy on tumors, as well as to assess the operation efficacy of the device.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hitachi's Heavy Ion Beam Therapy System HyBEAT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- treatment plan
- description
- Treatment plan performed by Hitachi's Heavy Ion Beam Therapy System HyBEAT will be designed to suit the particular needs of each subject and the course of treatment will differ for each subject depending on the type of tumor, varying from 1 day to 4 weeks. All subjects will be monitored for 12 weeks after receiving the last treatment.
- interventionNames
- Device: Hitachi's Heavy Ion Beam Therapy System HyBEAT
Primary outcomes (1)
- measure
- Adverse event
- timeFrame
- up to 12 weeks
- description
- The adverse reactions and the severity of all subjects in the early stage will be evaluated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must be 20 years of age inclusive, male or female 2. Diagnosed with one of the following cancer: head and neck cancer, lung cancer, liver cancer, prostate cancer, osteosarcoma or bone and soft-tissue tumours 3. Having a lesion of less than 12cm 4. Having no metastasis at distant organ sites 5. Having a life expectancy of more than 12 weeks or longer 6. ECOG Performance Status (ECOG PS): 0, 1 or 2 7. Maintain the function of major organs and satisfy the following criteria: WBC≥3,000 / mm3 , Plt ≥75,000 / mm3 (assuming no serious bleeding tendency below 100,000), Hb≥9.5 g / dl 8. Able to maintain body position during irradiation 9. Based on his/her free will, agree to participate in the clinical study and sign and date the informed consent form after understanding the clinical study. Exclusion Criteria: 1. Weigh more than or equal to 135kg 2. Subjects need chemotherapy or immunotherapy as concomitant treatment 3. Have received radiotherapy on the area planned to be irradiated 4. Have received local treatment that might potentially affect endpoint evaluation, 4 weeks prior to the screening process (for instance TACE etc.) 5. Have been treated with targeted therapy, chemotherapy or immunotherapy 4 weeks prior to the screening process 6. Participated in other clinical studies within 12 weeks before screening (studies using questionnaire are exemption) 7. Subjects contraindicated in using radiotherapy 8. Wearing electronic devices, for example implantable cardiac pacemakers, implantable defibrillators, cerebrospinal stimulators, artificial hearts and cochlear implants, where the function and activity may be affected by radiation 9. Have been diagnosed with another active, uncontrolled cancer 10. Subjects whose irradiated area has active or persistent infectious disease 11. Has autoimmune diseases or connective tissue diseases 12. Subjects with other serious complications 13. Pregnant or currently breastfeeding 14. Planning to give birth or unable to take contraception during the screening and treatment period, as well as within 52 weeks after receiving the last treatment, regardless of gender. 15. Subjects who are judged by the investigators as unsuitable
References
Publications (0)
Data not yet available
No reference posted for this study.