Clinical trial · Interventional
Varian ProBeam Proton Therapy System China Clinical Trial (Hefei)
NCT05463055CI-TRIAL-00082579ProBeamcompletedN/AResults postedClinicalTrials.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, two-center, single-arm objective performance criteria. This trial will be conducted in 2 clinical trial sites 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 to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing clinical evidence 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 |
|---|---|---|---|
| Proton Therapy System (ProBeam) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single-arm objective performance criteria
- description
- According to the National Medical Products Administration (NMPA) Guidance on Proton and Carbon Ion treatment system clinical evaluation and clinical trial, the participants with disease control should be at least 95%. The primary safety endpoints is that participants with Common Terminology Criteria for Adverse Events (CTCAE) grade 3 toxic reaction should be lower than 5%, CTCAE grade 4 and 5 toxic reaction rate is 0%. Therefore, the clinical trial did not have a control group, but using single-arm objective performance criteria.
- interventionNames
- Radiation: Proton Therapy System (ProBeam)
Primary outcomes (3)
- measure
- Percentage of Participants With Disease Control
- timeFrame
- 3 months ± 7 days after treatment completion, up to 24 weeks
- description
- Disease control refers to partial response and stable disease and complete response. Percentage of participants with disease control should be at least 95%. Tumor disease control measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). CT or MRI changes will be assessed before and after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria (Major Criteria): 1. 18≤ age≤ 80 years; 2. First-diagnosed patients with tumors of the nervous system, head and neck, chest, abdomen, spine, pelvic cavity, limbs, etc. by tissue/cell pathology; 3. Eastern Cooperative Oncology Group (ECOG) physical condition is graded as 0 to 2; 4. Women of childbearing had negative results in the blood pregnancy test (Human Chorionic Gonadotropin, HCG) 7 days prior to the first treatment; 5. 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. The subject with radiotherapy contraindications, including the known genetic tendencies that increase the sensitivity of normal tissue radiotherapy or the accompanying diseases that lead to hypersensitivity to radiotherapy; 2. The subject with other uncontrolled tumors except that to be treated according to medical history or the investigator's estimation, or with other malignant tumors within five years prior to enrollment; 3. Implanted pacemakers or other metal prosthesis within the scope of proton therapy; 4. Other situations that investigator determines not suitable for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.