Clinical trial · Interventional
To Explore the Safety and Efficacy of Hypervision Proton Surgery for Early-stage Non-small Cell Lung Cancer
A Phase I Clinical Study to Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer
NCT07195084CI-TRIAL-00107842HyPROS-LCrecruitingN/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 was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypervision proton surgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton radiotherpy
- description
- Proton radiotherapy 34GyE/f or 39GyE/f
- interventionNames
- Radiation: Hypervision proton surgery
Primary outcomes (2)
- measure
- The incidence of grade ≥ 3 psAEs at 1 month
- timeFrame
- 1 month after proton radiotherapy
- description
- Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
- measure
- The incidence of grade ≥ 3 psAEs at 1 year
- timeFrame
- 1 year after proton radiotherapy
- description
- Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient must be at least 18 years old * Karnofsky Performance Status \> 80 * NSCLC confirmed by cytology or histology; for subjects who cannot safely obtain pathological evidence due to factors such as tumor lesion location, patient's underlying diseases, or high puncture risk, after unanimous consent of the multidisciplinary team (MDT) discussion, they meet the clinical diagnostic criteria for NSCLC based on typical imaging features (such as enhanced chest CT and/or PET/CT) combined with clinical manifestations; * Early-stage tumors are defined as T1 (≤3cm) N0M0 based on enhanced computed tomography (CT) and positron emission tomography (PET) * The tumor must be more than 2 cm away from the proximal bronchial tree in all directions (the proximal bronchial tree is defined as 2 cm from the distal end of the trachea, the protrusion and the named lobar bronchus up to its first bifurcation) * FEV1 ≥ 1 L, FEV1 ≥ 40% of the predicted value (either one is sufficient); DLCO ≥ 40% of the predicted value * The patient can tolerate PET-CT examination * For female study participants of childbearing age, the urine or serum pregnancy test was negative within 7 days prior to the first administration of the study drug. If the result of the urine pregnancy test is positive, a blood pregnancy test is required Exclusion Criteria: * Other malignant tumors occurred concurrently within 2 years before enrollment * A history of chest radiotherapy in the past * It is planned to use other anti-tumor treatments within the regimen treatment (within 4 weeks)
References
Publications (0)
Data not yet available
No reference posted for this study.