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
The team will try a single high-dose Hypervision proton radiation treatment for people with early-stage peripheral non-small cell lung cancer to see if it is safe and works.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Anhui Provincial Cancer Hospital Academic / other |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT07195084 on ClinicalTrials.gov |
What this trial studies
This single-center, single-arm study used a dose-escalation, two-stage two-dose-group design to test single large fraction proton radiation delivered as either 34 GyE or 39 GyE for early peripheral NSCLC. Eligible tumors were T1 (≤3 cm) N0M0 located at least 2 cm from the proximal bronchial tree, and participants needed good performance status and adequate lung function. The primary focus was on safety and tolerability of the high single-fraction doses, with secondary attention to local control and short-term efficacy. Treatments were delivered at Anhui Provincial Hospital with pre-treatment imaging and multidisciplinary review guiding eligibility.
Who should consider this trial
Good fit: Adults with confirmed or clinically diagnosed early peripheral NSCLC (T1 ≤3 cm, N0M0) who have tumors ≥2 cm from the proximal bronchial tree, good performance status (KPS > 80), and adequate lung function (FEV1 ≥ 1 L or ≥ 40% predicted) are the intended candidates.
Not a fit: Patients with central or larger tumors, nodal or metastatic disease, poor performance status, or insufficient lung function are unlikely to benefit from this single high-dose peripheral-proton approach.
Why it matters
Potential benefit: If successful, this approach could provide a one-time high-dose proton option that controls small peripheral lung tumors while limiting exposure to nearby normal tissues.
How similar studies have performed: Photon stereotactic body radiotherapy for small peripheral NSCLC has shown good local control, but single-fraction high-dose proton treatments are relatively novel and have limited published data.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hefei, Anhui
- Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Shuanghu Yuan, PhD — Anhui Provincial Hospital
- Study coordinator: Shuanghu Yuan, PhD
- Email: yuanshuanghu@sina.com
- Phone: 0551-62894008
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.