Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Aarhus

About this trial

To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with colorectal liver metastases planned for resection

At least one tumor size >=3cm

Performance status 0-1

Disqualifiers

Liver cirrhosis

Extrahepatic metastases that can not be addressed curatively

Other malignant diseases within 5 years prior to diagnosis

Prior RFA treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • RFA (radiofrequency ablation)

    Device

    Preoperative RFA-induced partial necrosis of the liver metastasis

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Intervention (+RFA) armExperimental treatment 1 intervention
Group B: Control (-RFA) armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Median survival in each arm

Time frame
3 years

Secondary outcomes

1

One-year survival

One-year survival in each arm

Time frame
1 year
2

Two-year survival

Two-year survival in each arm

Time frame
2 years
3

Three-year survival

Three-year survival in each arm

Time frame
3 years
4

Recurrence rate

Recurrence rate at 1, 2, and 3 years follow-up

Time frame
1, 2, and 3 years

Other outcomes

1

Complications

Immediate postoperative complications (bleeding, surgical site infection, intraabdominal abscesses, bile leak)

Time frame
30-day postoperatively

Sponsors and contacts

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University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Rigshospitalet, Denmark

Collaborator