Overview
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.
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.
Eligibility
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.