Tumor, SolidProBeamNCT05463055

Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)

A study testing Proton Therapy System (ProBeam) in people with Tumor, Solid, run by Varian, a Siemens Healthineers Company at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Tumor, Solid
What is being tested?: Proton Therapy System (ProBeam)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteChina
Study dates: 26 Dec 2021to 3 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18≤ age≤ 80 years;
First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
Eastern Cooperative Oncology Group (ECOG) physical condition is graded as 0 to 2;
Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form.

Who cannot join

The subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy;
The subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment;
Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
Other situations that investigator determines not suitable for enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

Anhui Provincial Hospital
Hefei, Anhui, 230001

Other trials in China

About this study

This study is prospective, two-center, single-arm objective performance criteria. This trial will be conducted in 2 clinical trial sites with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing clinical evidence for the medical device registration.

Read the detailed description

Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors. 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 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 the end of the last radiotherapy session.

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.

Conditions: Tumor, Solid
Being tested: Proton Therapy System (ProBeam)
Keywords: Proton therapy, Radiation therapy, Tumor
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton Therapy System (ProBeam)Radiation
All of subjects (tumor patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors) will be treated with Proton radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam). 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 and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months ( for this trial). Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.

Study groups in NCT05463055
Study group	Role	What they receive
single-arm objective performance criteria	Experimental	According to the National Medical Products Administration (NMPA) Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, the participants with disease control should be at least 95%. 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. Receives: Radiation: Proton Therapy System (ProBeam)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Disease Control
Disease control refers to partial response and stable disease and complete response. Percentage of participants with disease control should be at least 95%.
Tumor disease control measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CT or MRI changes will be assessed before and after treatment.
Measured: 3 months ± 7 days after treatment completion, up to 24 weeks
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 not be accepted.
AEs occurred in the clinical trial are recorded and scored by the investigator according to CTCAE version 5.0.
Measured: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction
The percentage of subjects with toxic reactions of levels 4 and 5 should be 0%. If CTCAE level 4 and 5 toxic reaction occured, the clinical trial is considered as failure.
AEs occurred in the clinical trial are reported and scored by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Dec 20213 Nov 2022

First posted18 Jul 2022
Study start26 Dec 2021
Primary completion3 Nov 2022
Study completion3 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tumor, SolidStudies of the same condition, open and under way.
More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: a clinical study of prospective, single-arm objective performance criteria
Masking: None (open label)
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05463055
Sponsor's protocol ID: VAR-2021-03
Acronym: ProBeam
Status last verified: Sep 2024
First submitted: 21 Dec 2021
Last updated: 15 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Tumor, Solid trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)
ClinicalTrials.gov ID: NCT05463055
Acronym / sponsor ID: ProBeam / VAR-2021-03
Conditions: Tumor, Solid
Keywords: Proton therapy, Radiation therapy, Tumor
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
Study start: 26 Dec 2021 (actual)
Primary completion: 3 Nov 2022 (actual)
Study completion: 3 Nov 2022 (actual)
First posted: 18 Jul 2022 (actual)
Results: Posted 15 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: a clinical study of prospective, single-arm objective performance criteria

Arm	Type	Receives
single-arm objective performance criteria	Experimental	Radiation: Proton Therapy System (ProBeam)According to the National Medical Products Administration (NMPA) Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, the participants with disease control should be at least 95%. 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18≤ age≤ 80 years;
First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology;
Eastern Cooperative Oncology Group (ECOG) physical condition is graded as 0 to 2;
Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment;
The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form.

Key exclusion criteria (4 listed)

The subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy;
The subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment;
Implanted pacemakers or other metal prosthesis within the scope of proton therapy;
Other situations that investigator determines not suitable for enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Proton Therapy System (ProBeam)All of subjects (tumor patients, including tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs and other tumors) will be treated with Proton radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam). 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 and long-term follow-up, in which short-term follow-up will be 3 months after the end of the last treatment. Total expected participation for each subject from screening to the completion of short-term follow-up is a maximum duration of 12 weeks + 3 months ( for this trial). Long-term follow-up continues after the end of short-term follow-up until the 5th year after the end of the last radiotherapy session.	Radiation	single-arm objective performance criteria

Primary outcome

Percentage of Participants With Disease Control
Time frame: 3 months ± 7 days after treatment completion, up to 24 weeks
Disease control refers to partial response and stable disease and complete response. Percentage of participants with disease control should be at least 95%. Tumor disease control measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CT or MRI changes will be assessed before and after treatment.
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction
Time frame: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks
The percentage of participants with CTCAE grade 3 toxic reaction should be lower than 5%. Higher than 5% means worse outcome and will not be accepted. AEs occurred in the clinical trial are recorded and scored by the investigator according to CTCAE version 5.0.
Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction
Time frame: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks
The percentage of subjects with toxic reactions of levels 4 and 5 should be 0%. If CTCAE level 4 and 5 toxic reaction occured, the clinical trial is considered as failure. AEs occurred in the clinical trial are reported and scored by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Results and safety

Results posted to the registry on 15 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single-arm Objective Performance Criteria	47	45

Primary outcome: Percentage of Participants With Disease Control

Time frame: 3 months ± 7 days after treatment completion, up to 24 weeks. Number (95% Confidence Interval). Unit: percentage

Measure	Single-arm Objective Performance Criteria n = 45
Value	100 (92.1 to 100)

Primary outcome: Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 Toxic Reaction

Time frame: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks. Count of participants. Unit: Participants

Measure	Single-arm Objective Performance Criteria n = 47
Value	0

Primary outcome: Percentage of Participants With Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 and 5 Toxic Reaction

Time frame: From enrollment to 3 months ± 7 days after treatment completion, up to 24 weeks. Count of participants. Unit: Participants

Measure	Single-arm Objective Performance Criteria n = 47
Value	0

Adverse events

Time frame: The clinical trial started from subject 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 reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single-arm Objective Performance Criteria	1 of 47 (2.1%)	9 of 47 (19.1%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Tumor, Solid

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hongyan Zhang principal investigator

Anhui Provincial Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Proton Therapy System (ProBeam) in people with Tumor, Solid, run by Varian, a Siemens Healthineers Company at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Disease Control (time frame: 3 months ± 7 days after treatment completion, up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05463055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.