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NCT Number: NCT06347731

Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan)

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.

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Key information

Conditions

Tumor, Solid Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

About this study

Tumors sites include Intracranial, head and neck, chest, abdomen, spine, pelvic cavity, extremity and other sites. The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up which is 3 months after treatment completion and long-term follow-up which is 5 years after treatment completion. The clinical trial with short-term follow-up fulfills the requirements for NMPA regulatory registration. All the end points claimed will be achieved in the short-term follow-up stage. The trial is defined as completion once short-term follow-up is finished.

And long-term follow-up report will be submitted for future post market evaluation when requested by NMPA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.;

Treatment and study plan

Proton Radiation Therapy

Device

All enrolled participants will be treated with Proton radiation therapy using the medical device Varian ProBeam360° Proton Therapy System. The screening period from informed consent to enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period after the last treatment is divided into short-term follow-up which is 3 months after treatment completion and long-term follow-up which is 5 years after treatment completion.

Primary outcomes

  1. Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%)

    Time frame: Primary effectiveness outcome measured change from baseline to 3 months ± 7 days after treatment completion

    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.

  2. Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction

    Time frame: Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion

    The percentage of participants with CTCAE grade 3 toxic reaction should be lower than 5%. Higher than 5% means worse outcome and will be considered as failure. AEs occurred in the clinical trial are recorded and scored by the investigator according to CTCAE version 5.0.

  3. Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction

    Time frame: Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion

    The percentage of participants with toxic reaction of grade 4 and 5 should be 0%. If CTCAE grade 4 and 5 toxic reaction occured, It's not acceptable and the clinical trial is considered as failure.

    AEs occurred in the clinical trial are reported and scored by the investigator according to CTCAE version 5.0.

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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