Status:
NOT_YET_RECRUITING
To Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer
Lead Sponsor:
Anhui Provincial Cancer Hospital
Collaborating Sponsors:
Anhui Provincial Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 e...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 19 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07195084
Start Date
September 20 2025
End Date
September 19 2028
Last Update
September 26 2025
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