Status:
RECRUITING
Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)
Lead Sponsor:
Ion Beam Applications
Conditions:
Solid Tumor, Adult
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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® P...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT07153094
Start Date
August 4 2025
End Date
July 1 2031
Last Update
September 3 2025
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, China