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

NCT07195084 | Recruiting DMC

• 1 other identifier: HyPROS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

non-small cell lung cancer; Hypervision proton surgery

Outcome Measures

Primary Outcomes (2)

• The incidence of grade ≥ 3 psAEs at 1 month

  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

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

  1 year after proton radiotherapy

Secondary Outcomes (3)

• Primary tumor control at 1 year

  1 year after proton radiotherapy

• 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

  From date of treatment until the date of death

Study Arms (1)

Proton radiotherpy

EXPERIMENTAL

Proton radiotherapy 34GyE/f or 39GyE/f

Radiation: Hypervision proton surgery

Interventions

Hypervision proton surgery RADIATION

Proton radiaotherapy (34GyE or 39GyE)

Proton radiotherpy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead
• Anhui Provincial Hospital: collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

RECRUITING

Related Links

• A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer: NRG Oncology RTOG 0915 (NCCTG N0927)
• Long-term Follow-up on NRG Oncology RTOG 0915 (NCCTG N0927): A Randomized Phase 2 Study Comparing 2 Stereotactic Body Radiation Therapy Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shuanghu Yuan, PhD

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuanghu Yuan, PhD

CONTACT

0551-62894008; yuanshuanghu@sina.com

Li Li, PhD

CONTACT

0551-62894008; lililyde@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: September 26, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): September 19, 2027
• Study Completion (Estimated): September 19, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-02

Locations

CN (1)