NCT07195084Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 18 Sept 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Diseases
- Lung cancer
- NCT number
- NCT07195084
What you commit to
- Study type: Interventional
- Planned participants: 12
- From Sept 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other malignant tumors occurred concurrently within 2 years before enrollment
- A history of chest radiotherapy in the past
Other
- It is planned to use other anti-tumor treatments within the regimen treatment (within 4 weeks)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.