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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm objective performance criteria (OPC) | Other | 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%). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria (Major Criteria):
Exclusion Criteria (Major Criteria):
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| Name | Affiliation | Role |
|---|---|---|
| Kunyu Yang | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | China |
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Subjects meeting the inclusion/exclusion criteria and enrolled in the trial were treated with ProBeam360 Proton Therapy System (ProBeam360) unless the subject's status isn't fit for proton therapy prior to treatment during treatment planning and target area confirming. For example, if the subject's treatment plan indicated that within the target area wasn't suitable for radiation therapy, then should preclude from the trial.
The recruitment period was from September 2024 to December 2024. The location of the study was in medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | single-arm objective performance criteria | The target value for efficiency should be at least 80%, with an expected 95%. Among them, the effective definition is CR+PR+SD (complete response CR, partial response PR, disease stable SD). The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE grade 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. All enrolled subjects were treated with ProBeam Proton Therapy System. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months after treatment completion and long-term follow-up 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 finished. Long-term follow-up report will be submitted for future post market evaluation when requested by NMPA. Therefore, long-term follow-up result will not reported here. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm Objective Performance Criteria | The target value for efficiency should be at least 80%, with an expected 95%. Among them, the effective definition is CR+PR+SD (complete response CR, partial response PR, disease stable SD). The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE grade 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. All enrolled subjects were treated with ProBeam Proton Therapy System. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months after treatment completion and long-term follow-up is 5 years after treatment completion. The clinical trial with short-term follow-up fulfills the requirements for National Medical Products Administration (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 finished. Long-term follow-up report will be submitted for future post market evaluation when requested by NMPA. Therefore, long-term follow-up result will not reported here. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Primary effectiveness outcome measured change from baseline to 3 months ± 7 days after treatment completion |
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The clinical trial started from participant enrollment to 3 months ± 7 days after the last treatment, up to 24 weeks. Long-term follow-up report (from 3-month follow-up till 5 years) will be submitted for future post market evaluation when requested by NMPA. Therefore, long-term follow-up result will not be reported here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | single-arm objective performance criteria | The target value for efficiency should be at least 80%, with an expected 95%. Among them, the effective definition is CR+PR+SD (complete response CR, partial response PR, disease stable SD). The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE grade 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. All enrolled subjects were treated with ProBeam Proton Therapy System. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months after treatment completion and long-term follow-up 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 finished. Long-term follow-up report will be submitted for future post market evaluation when requested by NMPA. Therefore, long-term follow-up result will not reported here. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Investigations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sophia Shao | Varian Medical Systems | +86-21-23156400 | sophia.shao@varian.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2024 | Oct 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2025 | Oct 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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prospective, open-label, non-randomized, single-arm objective performance criteria
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| single-arm objective performance criteria (OPC) |
The target value for efficiency should be at least 80%, with an expected 95%. Among them, the effective definition is CR+PR+SD (complete response CR, partial response PR, disease stable SD). The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE grade 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria. All enrolled subjects were treated with ProBeam Proton Therapy System. The period after the last treatment is divided into short-term follow-up and long-term follow-up, in which short-term follow-up is 3 months after treatment completion and long-term follow-up 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 finished. Long-term follow-up report will be submitted for future post market evaluation when requested by NMPA. Therefore, long-term follow-up result will not reported here. |
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| Primary | 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. | Posted | Count of Participants | Participants | Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion |
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| Primary | 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. | Posted | Count of Participants | Participants | Primary safety outcome measured from enrollment to 3 months ± 7 days after treatment completion |
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| 1 |
| 47 |
| 6 |
| 47 |
| 40 |
| 47 |
| Cerebral ischemic lesion | Nervous system disorders | Non-systematic Assessment |
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| Type 2 respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| sudden death | General disorders | Non-systematic Assessment |
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| neutropenia | Investigations | Non-systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| renal insufficiency | Renal and urinary disorders | Non-systematic Assessment |
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| Elevated transaminase | Investigations | Non-systematic Assessment |
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| pulmonary infection | Infections and infestations | Non-systematic Assessment |
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| vomit | Gastrointestinal disorders | Non-systematic Assessment |
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| urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Weight loss | Metabolism and nutrition disorders | Non-systematic Assessment |
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| blood pressure elevation | Investigations | Non-systematic Assessment |
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