Trial Outcomes & Findings for Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin (NCT NCT03960021)

NCT ID: NCT03960021

Last Updated: 2025-10-24

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Day 1

Results posted on

2025-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Single arm Each patient is treated with 2 RFA interventions. RFA interventions: Each patient is treated with 2 RFA interventions. Abiopsy of one metastasis is done at each RF session. Histological samples are sent to the Bio-pathology department of Institut Bergonié for tumor infiltrating lymphocytes counting. Primary outcome results from this counting (stromal TILs ≥ 20% is considered as a significant level, a comparative measurement before and after RF will be performed). In parallel blood samples are performed before and after RFA to analyze the kinetics of peripheral blood T lymphocytes subsets, tumoral circulating cells and tumoral DNA.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Single arm Each patient is treated with 2 RFA interventions. RFA interventions: Each patient is treated with 2 RFA interventions. Abiopsy of one metastasis is done at each RF session. Histological samples are sent to the Bio-pathology department of Institut Bergonié for tumor infiltrating lymphocytes counting. Primary outcome results from this counting (stromal TILs ≥ 20% is considered as a significant level, a comparative measurement before and after RF will be performed). In parallel blood samples are performed before and after RFA to analyze the kinetics of peripheral blood T lymphocytes subsets, tumoral circulating cells and tumoral DNA.
Overall Study did not undergo the 2 radiofrequency ablations.	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single arm n=17 Participants Each patient is treated with 2 RFA interventions. RFA interventions: Each patient is treated with 2 RFA interventions. Abiopsy of one metastasis is done at each RF session. Histological samples are sent to the Bio-pathology department of Institut Bergonié for tumor infiltrating lymphocytes counting. Primary outcome results from this counting (stromal TILs ≥ 20% is considered as a significant level, a comparative measurement before and after RF will be performed). In parallel blood samples are performed before and after RFA to analyze the kinetics of peripheral blood T lymphocytes subsets, tumoral circulating cells and tumoral DNA.
Age, Continuous	70.8 years n=17 Participants
Sex: Female, Male Female	6 Participants n=17 Participants
Sex: Female, Male Male	11 Participants n=17 Participants
Region of Enrollment France	17 participants n=17 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Biological analyses could not be performed (technical reasons related to the machine). As such, it was not possible to assess this outcome and report summary statistics as expected. No attempt will be made in the future to collect and/or report the data

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 6

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 6

Outcome measures

Outcome data not reported

Adverse Events

Single arm

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single arm n=20 participants at risk Each patient is treated with 2 RFA interventions. RFA interventions: Each patient is treated with 2 RFA interventions. Abiopsy of one metastasis is done at each RF session. Histological samples are sent to the Bio-pathology department of Institut Bergonié for tumor infiltrating lymphocytes counting. Primary outcome results from this counting (stromal TILs ≥ 20% is considered as a significant level, a comparative measurement before and after RF will be performed). In parallel blood samples are performed before and after RFA to analyze the kinetics of peripheral blood T lymphocytes subsets, tumoral circulating cells and tumoral DNA.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • 1 year after radiofrequency ablation
General disorders Fever	10.0% 2/20 • Number of events 2 • 1 year after radiofrequency ablation
General disorders Pain	5.0% 1/20 • Number of events 1 • 1 year after radiofrequency ablation
Respiratory, thoracic and mediastinal disorders Atelectasis	5.0% 1/20 • Number of events 1 • 1 year after radiofrequency ablation
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	20.0% 4/20 • Number of events 5 • 1 year after radiofrequency ablation
Respiratory, thoracic and mediastinal disorders Pleural effusion	25.0% 5/20 • Number of events 5 • 1 year after radiofrequency ablation
Respiratory, thoracic and mediastinal disorders Pneumothorax	95.0% 19/20 • Number of events 37 • 1 year after radiofrequency ablation
Respiratory, thoracic and mediastinal disorders Respiratory; thoracic and mediastinal disorders - Other	5.0% 1/20 • Number of events 1 • 1 year after radiofrequency ablation
Skin and subcutaneous tissue disorders Subcutaneous emphysema	5.0% 1/20 • Number of events 1 • 1 year after radiofrequency ablation
Vascular disorders Hypertension	5.0% 1/20 • Number of events 1 • 1 year after radiofrequency ablation
Vascular disorders Vascular disorders - Other	5.0% 1/20 • Number of events 1 • 1 year after radiofrequency ablation

Additional Information

Pr Simone Mathoulin-Pélissier, Director of Clinical Trials Unit

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place