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.

Study Overview

• Status: Completed
• Conditions: Tumor, Solid
• Intervention / Treatment: Device: Proton Radiation Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: single-arm objective performance criteria (OPC); 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%).

Device: Proton Radiation Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%)	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.	Primary effectiveness outcome measured change from baseline to 3 months ± 7 days after treatment completion
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction	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.	Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction	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.	Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company
• Investigators: Principal Investigator: Kunyu Yang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Actual): April 4, 2025
• Study Completion (Actual): April 4, 2025

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Radiation therapy; Tumor; Proton therapy
• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Radiotherapy; Heavy Ion Radiotherapy; Proton Therapy
• Other Study ID Numbers: VAR-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No