Trial Outcomes & Findings for Varian ProBeam360° Proton Therapy System China Clinical Trial (Wuhan) (NCT NCT06347731)

Last Updated: 2025-12-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

47 participants

Primary outcome timeframe

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

Results posted on

2025-12-15

Participant Flow

The recruitment period was from September 2024 to December 2024. The location of the study was in medical clinic.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	47
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-arm Objective Performance Criteria n=47 Participants 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.
Age, Continuous	59.4 years STANDARD_DEVIATION 15.78 • n=47 Participants
Sex: Female, Male Female	21 Participants n=47 Participants
Sex: Female, Male Male	26 Participants n=47 Participants
Region of Enrollment China	47 participants n=47 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	single-arm objective performance criteria (OPC) n=43 Participants 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.
Effectiveness Measure: Tumor Disease Control Rate Reaches the Objective Performance Criteria (80%)	42 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	single-arm objective performance criteria (OPC) n=47 Participants 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.
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	single-arm objective performance criteria (OPC) n=47 Participants 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.
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction	0 Participants

Adverse Events

single-arm objective performance criteria

Serious events: 6 serious events

Other events: 40 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	single-arm objective performance criteria n=47 participants at risk 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.
Infections and infestations respiratory tract infection	4.3% 2/47 • Number of events 3 • 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.
Nervous system disorders Cerebral ischemic lesion	4.3% 2/47 • Number of events 3 • 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.
Respiratory, thoracic and mediastinal disorders Type 2 respiratory failure	2.1% 1/47 • Number of events 1 • 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.
General disorders sudden death	2.1% 1/47 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	single-arm objective performance criteria n=47 participants at risk 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.
Investigations Leukopenia	14.9% 7/47 • Number of events 8 • 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.
Investigations neutropenia	10.6% 5/47 • Number of events 7 • 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.
Respiratory, thoracic and mediastinal disorders cough	6.4% 3/47 • Number of events 3 • 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.
Renal and urinary disorders renal insufficiency	12.8% 6/47 • Number of events 6 • 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.
Investigations Elevated transaminase	6.4% 3/47 • Number of events 3 • 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.
Infections and infestations pulmonary infection	8.5% 4/47 • Number of events 4 • 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.
Gastrointestinal disorders vomit	8.5% 4/47 • Number of events 4 • 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.
Infections and infestations urinary tract infection	10.6% 5/47 • Number of events 5 • 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.
Blood and lymphatic system disorders anemia	8.5% 4/47 • Number of events 4 • 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.
Metabolism and nutrition disorders Weight loss	8.5% 4/47 • Number of events 4 • 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.
Investigations blood pressure elevation	8.5% 4/47 • Number of events 4 • 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.

Additional Information

Sophia Shao

Varian Medical Systems

Phone: +86-21-23156400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place