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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Other | Subjects will undergo radiation therapy using the investigational medical device (PROTEUS® PLUS) in accordance with the prescribed treatment plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Therapy (PBT) | Device | PROTEUS® PLUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short term efficacy evaluation | Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria | 90 days after the treatment completion |
| Short term safety evaluation | Toxicity of grade 3, 4 and 5 according to CTCAE | 90 days after the treatment completion |
| Measure | Description | Time Frame |
|---|---|---|
| Additional short term Safety evaluation | Toxicity of grade 1 and 2 according to CTCAE | 90 days after the treatment completion |
| Long term Efficacy evaluation | Disease Control Rate (DCR) |
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Inclusion Criteria (main):
Exclusion Criteria (main):
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| Name | Affiliation | Role |
|---|---|---|
| Lang Jinyi, MD | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital & Institute | Chengdu | Sichuan | China |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| 6 months, 1 year, 2 years, and 5 years after the end of the last treatment |
| Long term Safety evaluation | Toxicity of grade 1,2, 3, 4 and 5 according to CTCAE | 6 months, 1 year, 2 years, and 5 years after the end of the last treatment |