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Tests proton surgery for early-stage lung cancer

Tests a high-dose proton radiation treatment in adults with early non-small cell lung cancer.

Key facts

Who runs it
Anhui Provincial Cancer Hospital
Where
Hefei, ChinaSee the site
Trial code
Registry title
To Explore the Safety and Efficacy of Hypervision Proton Surgery for Early-stage Non-small Cell Lung Cancer
Status
Recruiting
People taking part
12 people, planned
Started
20 Sept 2025
Expected to end
19 Sept 2028
Type of study
Interventional
Treatments tested
  • Hypervision proton surgery
Record updated
13 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with early-stage non-small cell lung cancer (NSCLC) in the outer part of the lung. They would be treated with proton radiation given in one large dose.

Age
18 years or older
Sex
All sexes can join
Disease stage
Early-stage NSCLC: tumour T1 (3 cm (1.2 in) or smaller), N0M0, more than 2 cm (0.8 in) away from the main airways, confirmed by cytology or histology, or by imaging and a team decision if a biopsy is not safe
Earlier treatment
No chest radiotherapy in the past. No other anti-tumour treatment planned within 4 weeks of the trial treatment.

Main reasons for not taking part

  • Another cancer within 2 years before joining
  • Chest radiotherapy in the past
  • Other anti-tumour treatment planned within 4 weeks of the trial treatment

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 in China

  • Anhui Provincial HospitalHefei, ChinaContact: Shuanghu Yuan, PhDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Proton radiotherpyTreatment being tested

    Proton radiotherapy 34GyE/f or 39GyE/f

    Treatment: Hypervision proton surgery

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase I Clinical Study to Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer
Plain-language title
Tests proton surgery for early-stage lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 April 2026