NIPH Clinical Trials Search

BNCT for Unresectable FBPA-PET-Positive Tumors

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Tumor
Date of first enrollment	06/02/2026
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	Boron Neutron Capture Therapy (BNCT)

Outcome(s)

Primary Outcome

Proportion of acute non-hematologic adverse events of Grade 3 or higher Proportion of device-related malfunctions / Proportion of malfunctions The acute phase is defined as within 12 weeks from the date of treatment.

Secondary Outcome

Tumor Reduction Effect The tumor reduction effect will be defined as the proportion of target lesions achieving Complete Response (CR) or Partial Response (PR), evaluated according to the RECIST (Response Evaluation Criteria in Solid Tumors) Guideline (version 1.1). Duration of Response (DoR) The duration of response is defined as the interval from the date on which CR or PR is first achieved until the date when recurrence or progression is first confirmed. Disease Control Rate (DCR) The disease control rate is defined as the proportion of all eligible patients who demonstrate CR, PR, or Stable Disease (SD) in the target lesions within 12 weeks after BNCT administration. Complete Response Rate (CRR) The complete response rate is defined as the proportion of all eligible patients who achieve CR in the target lesions within 12 weeks after BNCT administration. Overall Assessment The overall treatment effect will be determined for each study participant based on the combination of tumor reduction in both target and non-target lesions within 12 weeks after BNCT administration, in accordance with the overall response criteria of the RECIST Guideline (version 1.1).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1.Written informed consent for participation in this study has been obtained at the time of enrollment. 2.Patients aged 18 years or older (no restriction on sex). 3.Patients with a confirmed diagnosis of unresectable malignant tumor who meet the following condition: -A board-certified radiologist confirms FBPA accumulation within the tumor on FBPA-PET, with a higher Standardized Uptake Value (SUVmax or SUVmean) compared with normal tissue. 4.Patients with at least one measurable tumor lesion confirmed by CT or MRI. The tumor must have a maximum diameter of 20 cm or less. For lymph node metastases, involvement is limited to the regional lymph node area or a single nodal region; for other metastatic tumors, the number of lesions must be three or fewer. 5.The tumor must be contained within a single irradiation field. (Maximum diameter: 20 cm; depth: 7 cm) 6.Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 7.Patients who are able to comply with the required visit schedule. 8.Patients who meet dose constraints for normal organs and are eligible to receive a curative dose to the tumor. 9.Patients whose most recent laboratory results within 4 weeks prior to registration meet all of the following: 1) White blood cell count >= 2,000/mm^3 2) Neutrophil count >= 1,500/mm^3 3) Hemoglobin >= 7.0 g/dL 4) Platelet count >= 100,000/mm^3 5) Serum creatinine <= 1.5 mg/dL 6) Total bilirubin <= 1.5 mg/dL 7) AST (GOT) <= 100 IU/L 8) ALT (GPT) <= 100 IU/L 10.Patients expected to survive for at least 12 weeks after BNCT administration.
Exclude criteria	1.Patients with unresectable recurrent thoracic solid malignant tumors, including esophageal cancer, non-small cell lung cancer, breast cancer, malignant soft tissue sarcoma, malignant pleural mesothelioma, or malignant peripheral nerve sheath tumors. 2.Patients with active double cancer (synchronous double cancer or metachronous double cancer with a disease-free interval of 5 years or less). 3.Patients with distant metastatic lesions. 4.Patients with pulmonary fibrosis or interstitial pneumonia who have severe symptoms requiring home oxygen therapy, who have limitations in activities of daily living, or who require supplemental oxygen. 5.Patients with active dermatologic toxicity caused by anticancer drugs. 6.Patients with hereditary fructose intolerance. 7.Patients with phenylketonuria. 8.Patients with comorbidities that may make the conduct of this therapy difficult, such as severe cardiac disease (NYHA Class III or IV), renal failure requiring dialysis, hepatic failure (Child-Pugh Class C), severe respiratory disease (home oxygen therapy), uncontrolled diabetes mellitus, or uncontrolled hypertension. 9.Patients with infections requiring systemic treatment. 10.Women who wish to become pregnant during the study period, pregnant women, or breastfeeding women. 11.Patients with implanted active medical devices such as cardiac pacemakers or implantable cardioverter-defibrillators. 12.Patients participating in other clinical studies or trials whose primary endpoint has not yet been completed, or whose participation is expected to interfere with the evaluation of this study. However, this does not apply when the primary endpoint of the prior study is survival follow-up. 13.Other patients deemed ineligible by the principal investigator or sub-investigators.