Clinical trial · Interventional
Varian ProBeam Proton Therapy System Clinical Trial (Shandong)
NCT06340815CI-TRIAL-00104918completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is prospective, single-center, single-arm objective performance criteria. This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumor, Solid | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: Proton Therapy System (ProBeam) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm objective performance criteria (OPC)
- description
- According to the NMPA Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, the objective performance criteria for the validity of medical device treatment for trial use should be at least 80%, with an expected target of 95% in which the validity is defined as: Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD), and the definition of tumor disease control rate in this clinical trial is basically identical. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria, when evaluating ProBeam radiotherapy for tumor patients, the main validity evaluation index of tumor disease control rate; the main safety evaluation by incident of acute radiation injury and adverse event.
- interventionNames
- Device: Radiation: Proton Therapy System (ProBeam)
Primary outcomes (3)
- measure
- Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion
- timeFrame
- 90 days ± 7 days after treatment completion
- description
- At 90 days after the end of treatment, the number of cases in partial response (PR) and stable disease (SD) and complete response (CR) accounted for the proportion of total cases will be graded based on Response Evaluation Criteria in Solid Tumors RECIST Version 1.1 (RECIST 1.1) criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria (Major Criteria): 1. Patients diagnosed with histological/pathological diagnosis and/or with imaging, laboratory examination and other evidence, clinically diagnosed as benign and malignant intracranial tumors, and malignant solid tumors of the head and neck, chest, abdomen, spine, pelvis, and extremities; 2. Eastern Cooperative Oncology Group (ECOG) physical condition grade ≤ 2; 3. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment; 4. The subject or subject's guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the protocol and sign informed consent form. Exclusion Criteria (Major Criteria): 1. There are contraindications to radiation therapy, including congenital susceptibility to ionizing radiation hypersensitivity; or the presence of comorbidity that may lead to ionizing radiation hypersensitivity, which will increase the sensitivity of normal tissues to radiation therapy; 2. The tumor recurring at the same site has received two or more radiotherapy treatments; 3. Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether they are turned on or not) within the scope of radiotherapy ; or passive implants that affect radiotherapy thing; 4. Other situations that investigator determines not suitable for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.