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

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.

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.

Conditions2

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