Clinical trial · Interventional
The DRAGON 2 Trial
An International Multicenter Randomized Controlled Trial to Compare Combined Portal and Hepatic Vein Embolization (PVE/HVE) with PVE Alone in Patients with Colorectal Liver Cancer Metastases (CRLM) and a Small Future Liver Remnant (FLR)
NCT05428735CI-TRIAL-00082140DRAGON 2recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Liver Metastases (CRLM) | — | UNRESOLVED | — |
| Small Future Liver Remnant (FLR) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Portal Vein Embolization (PVE) alone - (control arm)
- description
- Portal Vein Embolization (PVE) alone
- interventionNames
- Procedure: Embolization
- type
- EXPERIMENTAL
- label
- Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
- description
- Combined Portal and Hepatic Vein Embolization (PVE/HVE) - (interventional arm)
- interventionNames
- Procedure: Embolization
Primary outcomes (2)
- measure
- Volume sufficient for resection at week 3 after the embolization
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with primarily unresectable/ potentially resectable CRLM with a FLR \<30% (\<40% in chemotherapy damaged livers) * Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or simultaneously during one of the liver procedures. * Patients with resectable or ablatable lung or brain metastases can be included (statement about the resectability of these extrahepatic metastases by a tumor board needs to be available) * 18 Years and older * Men and women * Able to understand the trial and provide informed consent. Exclusion Criteria: * Pregnant or lactating female. * Premenopausal females not able or willing to commit to oral contraception * Patients with prohibitive comorbidities, decision made by local team * Any patient with non-resectable or non-ablatable extrahepatic disease * Patients with hepatic malignancies other than CRLM * Progression of disease by RECIST criteria after cytoreduction chemotherapy * Complete response after conversion chemotherapy * Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease * The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.
References
Publications (0)
Data not yet available
No reference posted for this study.