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

NCT07137195 | Active Not Recruiting

• 1 other identifier: IBA-01-ZZ
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.

Conditions

Solid Tumor, Adult

Keywords

Proton Therapy

Outcome Measures

Primary Outcomes (2)

• Short term efficacy evaluation

  Disease Control Rate (DCR) according to Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria

  90 days after the treatment completion

• Short term safety evaluation

  Toxicity of grade 3, 4 and 5 according to CTCAE

  90 days after the treatment completion

Secondary Outcomes (3)

• Additional short term Safety evaluation

  90 days after the treatment completion

• Long term Efficacy evaluation

  6 months, 1 year, 2 years and 5 years after the treatment completion

• Long term Safety evaluation

  6 months, 1 year, 2 years, and 5 years after the treatment completion

Study Arms (1)

Treatment Arm

OTHER

Subjects will undergo radiation therapy using the investigational medical device (PROTEUS® PLUS) in accordance with the prescribed treatment plan.

Device: Proton Beam Therapy (PBT)

Interventions

Proton Beam Therapy (PBT) DEVICE

PROTEUS® PLUS

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ion Beam Applications: lead

Study Sites (1)

Hebei Yizhou Cancer Hospital

Zhuozhou, Hebei, China

Location

MeSH Terms

Interventions

Proton Therapy

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Jingbo Kang, MD

  Hebei Yizhou Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 22, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): September 5, 2026
• Study Completion (Estimated): July 31, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)