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

N/AActive Not RecruitingNCT07153094

Ion Beam Applications47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor, Adult

Interventions

Proton Beam Therapy (PBT)DEVICE

PROTEUS® PLUS

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, China

Outcomes

Primary Outcomes

Short term efficacy evaluation

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

Time frame: 90 days after the treatment completion

Short term safety evaluation

Toxicity of grade 3, 4 and 5 according to CTCAE

Time frame: 90 days after the treatment completion

Secondary Outcomes

Additional short term Safety evaluation

Toxicity of grade 1 and 2 according to CTCAE

Time frame: 90 days after the treatment completion

Long term Efficacy evaluation

Disease Control Rate (DCR)

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

Long term Safety evaluation

Toxicity of grade 1,2, 3, 4 and 5 according to CTCAE

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

Data from ClinicalTrials.gov

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