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NCT06185556: COLDFIRE-III
COLDFIRE-III Trial: Efficacy of Irreversible Electroporation and Stereotactic Body Radiotherapy for Perivascular and Peribiliary Colorectal Liver Metastases
Phase 2, PHASE3 trial testing Irreversible electroporation in Colorectal Cancer in 78 participants. Currently enrolling.
1 September 2029
Quick facts
| Lead sponsor | Amsterdam UMC, location VUmc |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 20 August 2024 |
| Primary completion | 1 September 2029 |
| Estimated completion | 1 September 2031 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Irreversible electroporation
- Stereotactic body radiotherapy
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Liver Metastases — all drugs for Liver Metastases →
- Liver Metastasis Colon Cancer — all drugs for Liver Metastasis Colon Cancer →
- Unresectable Solid Tumor — all drugs for Unresectable Solid Tumor →
Sponsor
Amsterdam UMC, location VUmc — full company profile →
Who can join
18 and older, any sex, with Colorectal Cancer or Liver Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this phase IIb/III, prospective, randomized clinical trial is to compare the efficacy of irreversible electroporation (IRE) with stereotactic body radiotherapy (SBRT) in patients with perivascular or peribiliary colorectal liver metastases (CRLM), that are not amenable for surgical resection or thermal ablation. Efficacy is assessed in terms of local control at 2 years.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Consensus Guidelines of Irreversible Electroporation for Pancreatic Tumors: Protocol Standardization Using the Modified Delphi Technique.
Vos DJW, Ruarus AH, Timmer FEF, Geboers B, et al · · 2024 · cited 2× · PMID 38993594 · DOI 10.1055/s-0044-1787164 -
Thermal Ablation Versus Surgical Resection for Intermediate-Size (3-5 cm) Colorectal Liver Metastases: Results from the Amsterdam Colorectal Liver Met Registry (AmCORE).
Dijkstra M, van der Lei S, Schulz HH, Buffart TE, et al · · 2026 · PMID 41899620 · DOI 10.3390/cancers18061017
Verify or expand the search:
- PubMed search for NCT06185556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Irreversible electroporation
Trials testing the same drug.
- NCT07306273 — IRE Combined With the Dual-Function Antibody PD-1/CTLA-4 for the Treatment of LAPC Following Failure of First-Line AG Th · Phase 2 · recruiting
- NCT06677762 — Irreversible Electroporation Ablation Combined With Anti-PD(L)1 Therapy for Locally Advanced Pancreatic Cancer · not yet recruiting
- NCT05609656 — Electroporation and Immunotherapy in Metastatic Colorectal Cancer · Phase 2 · terminated
- NCT04717687 — Pilot Study on the Evaluation of Irreversible Electroporation Technique in Infiltrating Perihilar Cholangiocarcinoma · NA · withdrawn
- NCT04404647 — Irreversible Electroporation of Unresectable Liver Tumors · NA · withdrawn
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
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- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting
Other Amsterdam UMC, location VUmc trials
Trials by the same sponsor.
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- NCT07155681 — Evaluating Healthcare Professionals' Satisfaction and Stress Mitigation Using Virtual Reality Intervention in Surgical W · NA · not yet recruiting
- NCT06416345 — Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06185556 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amsterdam UMC, location VUmc
- Last refreshed: 23 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06185556.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing