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

Anhui Provincial Cancer Hospital

Status

Not yet enrolling

Conditions

Non-Small Cell Lung Cancer

Treatments

Radiation: Hypervision proton surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT07195084

HyPROS

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must be at least 18 years old
Karnofsky Performance Status > 80
NSCLC confirmed by cytology or histology
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)