Clinical trial · Interventional
Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei)
Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS for Radiation Therapy in Oncology Patients
NCT07137195CI-TRIAL-00104097active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Beam Therapy (PBT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment Arm
- description
- Subjects will undergo radiation therapy using the investigational medical device (PROTEUS® PLUS) in accordance with the prescribed treatment plan.
- interventionNames
- Device: Proton Beam Therapy (PBT)
Primary outcomes (2)
- measure
- Short term efficacy evaluation
- timeFrame
- 90 days after the treatment completion
- description
- Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria
- measure
- Short term safety evaluation
- timeFrame
- 90 days after the treatment completion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria (main): * 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 Exclusion Criteria (main): * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.