N/A
Completed N=47
Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)
Tumor, Solid
Source: ClinicalTrials.gov NCT06347731 ↗
Enrolled (actual)
47
Serious AEs
12.8%
Results posted
Dec 2025
Primary outcomePrimary: Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%) — 42 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%) |
42 | — |
| PRIMARY Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction |
— | — |
| PRIMARY Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction |
— | — |
Eligibility Criteria
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.;
Data sourced from ClinicalTrials.gov (NCT06347731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.