Clinical Trials in China / NCT07153094
Active, not recruiting
Not applicable
Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Shenzhen)
NCT07153094 · tracked via the Priya Life Science China tracker
Condition(s) studied
Solid Tumor, Adult
Investigational drug(s) / intervention(s)
Proton Beam Therapy (PBT)
Proton Beam Therapy (PBT): PROTEUS® PLUS
Study 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
Primary outcome measure(s)
- Short term efficacy evaluation — 90 days after the treatment completion
Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria - Short term safety evaluation — 90 days after the treatment completion
Toxicity of grade 3, 4 and 5 according to CTCAE
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center | Shenzhen | China |
More Ion Beam Applications trials in China
Clinical Trial of the Safety and Efficacy of IBA Proton Therapy System PROTEUS® PLUS (Hebei)
Active, not recruiting
Other trials for the same condition
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07153094 on ClinicalTrials.gov ↗ ← All trials in China