CClinicalTrials.gg
RecruitingNCT07195084HyPROS-LCUpdated Apr 13, 2026

To Explore the Safety and Efficacy of Hypervision Proton Surgery for Early-stage Non-small Cell Lung Cancer

An interventional study of Hypervision proton surgery in Non-Small Cell Lung Cancer, sponsored by Anhui Provincial Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Anhui Provincial Cancer Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

This study adopted a dose escalation protocol (an improved "two-stage two-dose group" design) to explore the safety and efficacy of visual proton surgery (single large fractionated doses of 34GyE and 39GyE) in the treatment of early peripheral NSCLC.

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Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • non-small cell lung cancer; Hypervision proton surgery
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 12 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Anhui Provincial Cancer Hospital is the lead sponsor of 24 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Proton radiotherpy

    Proton radiotherapy 34GyE/f or 39GyE/f

    Radiation: Hypervision proton surgery

Interventions

  • RadiationHypervision proton surgery

    Proton radiaotherapy (34GyE or 39GyE)

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What researchers measure

Primary outcomes

  1. The incidence of grade ≥ 3 psAEs at 1 month

    Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: 1 month after proton radiotherapy

  2. The incidence of grade ≥ 3 psAEs at 1 year

    Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)

    Time frame: 1 year after proton radiotherapy

Secondary outcomes

  1. Primary tumor control at 1 year

    Primary tumor control at 1 year

    Time frame: 1 year after proton radiotherapy

  2. Disease-free survival time

    Disease-free survival time

    Time frame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  3. Overall survival time

    Overall survival time

    Time frame: From date of treatment until the date of death

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Study locations

1 of 1 sites recruiting
  • Anhui Provincial Hospital
    Hefei, Anhui 230001, China
    • Shuanghu Yuan, PhD · Contact · yuanshuanghu@sina.com · 0551-62894008
    • Li Li, PhD · Contact · lililyde@163.com · 0551-62894008
    • Shuanghu Yuan, PhD · Principal investigator
    • Li Li, PhD · Sub investigator
    Recruiting
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07195084
Lead sponsor
Anhui Provincial Cancer Hospital
Collaborators
Anhui Provincial Hospital
Responsible party
Shuanghu Yuan (Professor, Anhui Provincial Hospital) — Principal investigator
First posted
Sep 26, 2025
Start date
Sep 20, 2025
Primary completion
Sep 19, 2027 (estimated)
Completion
Sep 19, 2028 (estimated)
Last update
Apr 13, 2026

Study contacts

Shuanghu Yuan, PhD
Contact
yuanshuanghu@sina.com
0551-62894008
Li Li, PhD
Contact
lililyde@163.com
0551-62894008
Shuanghu Yuan, PhD
principal investigator · Anhui Provincial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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