Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)

Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)

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.

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