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

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

Overview

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.

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.

Interventions

• Radiation Hypervision proton surgery
  Proton radiaotherapy (34GyE or 39GyE)

Primary outcome measures

• The incidence of grade ≥ 3 psAEs at 1 month [Time frame: 1 month after proton radiotherapy]
• The incidence of grade ≥ 3 psAEs at 1 year [Time frame: 1 year after proton radiotherapy]

Secondary outcome measures (3)

• Primary tumor control at 1 year [Time frame: 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]
• Overall survival time [Time frame: From date of treatment until the date of death]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Anhui Provincial Hospital — Hefei

Identifiers

NCT: NCT07195084 · HyPROS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗