Clinical trial · Interventional
Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)
NCT06347731CI-TRIAL-00098962completedN/AResults postedClinicalTrials.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)
This study is a clinical trial of prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 participants enrolled. All participants will be treated with radiation therapy using the medical device of Varian ProBeam360° Proton Therapy System (ProBeam360°), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.
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 |
|---|---|---|---|
| Tumor, Solid | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Radiation Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single-arm objective performance criteria (OPC)
- description
- According to the National Medical Products Administration (NMPA) Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, The expected effective rate is 95%, and the target value is set at 80% of which the effective is defined as: tumor disease control rate = number of Complete Response (CR)+ Partial Response (PR)+ Stable Disease (SD)/the total number of subject\*100%. Therefore, the clinical trial does not have a control group, but using single-arm objective performance criteria to evaluate ProBeam360 radiotherapy; the primary safety evaluation indicators is that CTCAE grade 3 toxic reaction ratio is lower than the acceptable value (5%), CTCAE grade 4 and 5 toxic reaction ratio is acceptable value (0%).
- interventionNames
- Device: Proton Radiation Therapy
Primary outcomes (3)
- measure
- Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%)
- timeFrame
- Primary effectiveness outcome measured change from baseline to 3 months ± 7 days after treatment completion
- description
- At 3 months after the treatment completion, Disease control rate (DCR)will be assessed according to RECIST 1.1 criteria. DCR= The number of（complete response (CR)+partial response (PR)+stable disease (SD) ）/Total number of subject\*100%. Tumor assessment measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1). CR, PR or SD were assessed through tumor size changes in CT or MRI images before and after treatment until 3-month follow-up visit. The target value for the main effectiveness evaluation (DCR) of the trial is 80% at 3 months after the end of the last radiotherapy session. If the lower limit of the 95% confidence interval of the experimental results is not less than 80%, then the DCR meets the trial Objective.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria (Major Criteria): * Confirmed by cellular or histopathological diagnosis and/or evidence of imaging or laboratory tests, with a clinical diagnosis of benign, Patients with malignant intracranial tumors, as well as malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremity; * The target lesion is a measurable solid tumor, and the longest diameter of the lesion should be ≥10mm; * Those who have an expected survival time of more than 6 months; * Eastern Cooperative Oncology Group (ECOG) physical status is graded as 0\~2; * Females of childbearing potential with a negative blood or urine pregnancy test result within 7 days prior to the first treatment; Exclusion Criteria (Major Criteria): * Patients with contraindications to radiation therapy, including those with a known genetic predisposition to enhance the sensitivity of normal tissue radiotherapy or concomitant conditions leading to hypersensitivity to radiotherapy * Patients with uncontrolled tumors other than the tumors to be treated, or patients with extensive metastases based on medical history or as judged by the investigator * Proton radiation therapy area includes implanted pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether turned on or not); or passive implants that affect radiotherapy * Tumor interventional treatment for the same lesion within 30 days prior to screening, such as transarterial chemoembolization (TACE), thermal ablation, etc.;
References
Publications (0)
Data not yet available
No reference posted for this study.