Solid Tumor, AdultNCT07137195
Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei)
A study testing Proton Beam Therapy (PBT) in people with Solid Tumor, Adult, run by Ion Beam Applications at 1 site in China.
Trial summary
This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device. The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Proton Beam Therapy (PBT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2025to 31 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinically diagnosed with benign/malignant intracranial tumor and malignant solid tumor of head and neck, chest, abdomen, spine, pelvic cavity and limbs
- At least 1 lesion of the tumor to be treated is measurable according to RECIST criteria
- Expected survival time of more than 6 months
- ECOG performance status of 0 to 2
- Negative pregnancy test (HCG) results within 7 days prior to the first treatment for females of childbearing potential
Who cannot join
- Contraindications to radiation therapy
- Presence of other uncontrolled tumors other than the tumor to be treated
- Implants and devices in the treatment area
- Re-irradiation
- Other conditions that are not suitable for inclusion, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS for Radiation Therapy in Oncology Patients
This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device.
The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.
Read the detailed description
The trial is structured in two distinct phases. Phase 1 - Clinical Trial: This phase spans from the initial screening through to 90 days post-treatment. Its primary objective is to assess the efficacy and safety of PROTEUS® PLUS in accordance with the regulatory requirements set by the National Medical Products Administration (NMPA) for product registration. Phase 2 - Long-Term Follow-Up: Extending up to five years after treatment, this phase aims to monitor the long-term efficacy and safety of PROTEUS® PLUS. Periodic reports will be submitted in compliance with NMPA guidelines.
- Conditions
- Solid Tumor, Adult
- Being tested
- Proton Beam Therapy (PBT)
- Keywords
- Proton Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam Therapy (PBT)Device
PROTEUS® PLUS
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Subjects will undergo radiation therapy using the investigational medical device (PROTEUS® PLUS) in accordance with the prescribed treatment plan. Receives: Device: Proton Beam Therapy (PBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term efficacy evaluation
Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria
Measured: 90 days after the treatment completion
Short term safety evaluation
Toxicity of grade 3, 4 and 5 according to CTCAE
Measured: 90 days after the treatment completion
Secondary outcomes (3)
Additional short term Safety evaluation
Toxicity of grade 1 and 2 according to CTCAE
Measured: 90 days after the treatment completion
Long term Efficacy evaluation
Disease Control Rate (DCR)
Measured: 6 months, 1 year, 2 years and 5 years after the treatment completion
Long term Safety evaluation
Toxicity of grade 1,2, 3, 4 and 5 according to CTCAE
Measured: 6 months, 1 year, 2 years, and 5 years after the treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start29 Apr 2025
- Primary completion31 Aug 2026
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ion Beam Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingbo Kang, MD, Principal investigator, Hebei Yizhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137195
- Sponsor's protocol ID
- IBA-01-ZZ
- Status last verified
- Nov 2026
- First submitted
- 1 Aug 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS for Radiation Therapy in Oncology Patients
- ClinicalTrials.gov ID
- NCT07137195
- Acronym / sponsor ID
- IBA-01-ZZ
- Conditions
- Solid Tumor, Adult
- Keywords
- Proton Therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Ion Beam ApplicationsIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device.
The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.
Detailed description
The trial is structured in two distinct phases. Phase 1 - Clinical Trial: This phase spans from the initial screening through to 90 days post-treatment. Its primary objective is to assess the efficacy and safety of PROTEUS® PLUS in accordance with the regulatory requirements set by the National Medical Products Administration (NMPA) for product registration. Phase 2 - Long-Term Follow-Up: Extending up to five years after treatment, this phase aims to monitor the long-term efficacy and safety of PROTEUS® PLUS. Periodic reports will be submitted in compliance with NMPA guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Device: Proton Beam Therapy (PBT)Subjects will undergo radiation therapy using the investigational medical device (PROTEUS® PLUS) in accordance with the prescribed treatment plan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically diagnosed with benign/malignant intracranial tumor and malignant solid tumor of head and neck, chest, abdomen, spine, pelvic cavity and limbs
- At least 1 lesion of the tumor to be treated is measurable according to RECIST criteria
- Expected survival time of more than 6 months
- ECOG performance status of 0 to 2
- Negative pregnancy test (HCG) results within 7 days prior to the first treatment for females of childbearing potential
Key exclusion criteria (5 listed)
- Contraindications to radiation therapy
- Presence of other uncontrolled tumors other than the tumor to be treated
- Implants and devices in the treatment area
- Re-irradiation
- Other conditions that are not suitable for inclusion, as judged by the investigator.
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 Beam Therapy (PBT)PROTEUS® PLUS | Device | Treatment Arm |
Primary outcome
Short term efficacy evaluation
Time frame: 90 days after the treatment completion
Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria
Short term safety evaluation
Time frame: 90 days after the treatment completion
Toxicity of grade 3, 4 and 5 according to CTCAE
3 secondary outcomes
Additional short term Safety evaluation
Time frame: 90 days after the treatment completion
Long term Efficacy evaluation
Time frame: 6 months, 1 year, 2 years and 5 years after the treatment completion
Long term Safety evaluation
Time frame: 6 months, 1 year, 2 years, and 5 years after the treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Jingbo Kang, MD principal investigator
Hebei Yizhou Cancer 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 Beam Therapy (PBT) in people with Solid Tumor, Adult, run by Ion Beam Applications 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 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Short term efficacy evaluation (time frame: 90 days after the treatment completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.