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

April 7, 2026 updated by: Shuanghu Yuan, Anhui Provincial Cancer Hospital

A Phase I Clinical Study to Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuanghu Yuan, PhD
        • Sub-Investigator:
          • Li Li, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proton radiotherpy
Proton radiotherapy 34GyE/f or 39GyE/f
Radiation: Hypervision proton surgery
Proton radiaotherapy (34GyE or 39GyE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of grade ≥ 3 psAEs at 1 month
Time Frame: 1 month after proton radiotherapy
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
1 month after proton radiotherapy
The incidence of grade ≥ 3 psAEs at 1 year
Time Frame: 1 year after proton radiotherapy
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
1 year after proton radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary tumor control at 1 year
Time Frame: 1 year after proton radiotherapy
Primary tumor control at 1 year
1 year after proton radiotherapy
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
Disease-free survival time
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
Overall survival time
Time Frame: From date of treatment until the date of death
Overall survival time
From date of treatment until the date of death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Cancer Hospital

Collaborators

Anhui Provincial Hospital

Investigators

  • Principal Investigator: Shuanghu Yuan, PhD, Anhui Provincial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2025

Primary Completion (Estimated)

September 19, 2027

Study Completion (Estimated)

September 19, 2028

Study Registration Dates

First Submitted

September 18, 2025

First Submitted That Met QC Criteria

September 25, 2025

First Posted (Actual)

September 26, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HyPROS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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