Trial Outcomes & Findings for Bronchoscopic Cryo-Immunotherapy of Lung Cancer (NCT NCT04049474)
NCT ID: NCT04049474
Last Updated: 2025-04-24
Results Overview
Success is defined as identification of the target peripheral lung tumor by radial endobronchial ultrasound within 20 minutes followed by completed cryoablation of target tumor.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Day 0 (Intraoperative)
Results posted on
2025-04-24
Participant Flow
Participant milestones
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Baseline characteristics by cohort
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=21 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (Intraoperative)Success is defined as identification of the target peripheral lung tumor by radial endobronchial ultrasound within 20 minutes followed by completed cryoablation of target tumor.
Outcome measures
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=21 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Percentage of Successful Performances Among Patients in Whom BCI is Attempted
|
100 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 7 Post-BCIOutcome measures
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=21 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Percentage of Patients Who Experience Bleeding Complications
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 7 Post-BCIOutcome measures
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=21 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=21 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Length of Time to Perform BCI
|
17 Seconds
Interval 11.5 to 32.65
|
PRIMARY outcome
Timeframe: Day 0Outcome measures
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=21 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Length of Fluoroscopy Exposure During BCI
|
201 Seconds
Interval 135.0 to 284.5
|
PRIMARY outcome
Timeframe: Up to Day 7 Post-BCIIncidence of National Cancer Institute Common Terminology Criteria for Adverse Events Grade 4 or 5 adverse events that may be possibly, probably, or definitely related to BCI.
Outcome measures
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=21 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Day 14 Post-BCIThe number of patients whose peripheral blood CD8+ T cells (collected via blood sample) display at least one combination of the following markers after BCI: HLA-DR, CD38, Ki-67, Bcl-2, or PD-1.
Outcome measures
| Measure |
Bronchoscopic Cryo-Immunotherapy (BCI)
n=12 Participants
BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation.
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description.
|
|---|---|
|
Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers
|
50 Percentage of participants
|
Adverse Events
Bronchoscopic Cryo-Immunotherapy (BCI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place