The DRAGON 2 Trial
In the randomized controlled DRAGON 2 trial study subjects will be randomized between two arms, PVE alone (control group) and PVE/HVE (interventional group).
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05428735.
Locations matching your search criteria
United States
Connecticut
New Haven
Resection of liver metastases from colorectal cancer (CRLM) improves survival compared to
chemotherapy alone and may lead to cure in up to 40% of patients. Extended liver
resections are sometimes necessary to resect primarily unresectable/ potentially
resectable (PU/PR) colorectal liver metastases. These resections are generally performed
if the volume of the future liver remnant (FLR) comprises at least 30% of the total
volume of the liver (without the volume of the metastases) or when liver function of the
FLR on technetium-99m (99mTc) scintigraphy exceeds 2.67%/min/m2.
When this liver volume or function criterion is not met, a high chance of
post-hepatectomy liver failure exists. To prevent this, the induction of liver
regeneration between a two-stage hepatectomy is commonly performed.
The current standard procedure to induce regeneration is the embolization of the portal
vein branches to the tumor carrying liver (PVE) to induce hypertrophy of the remaining
part of the liver which will serve as the FLR. Recently, combined embolization of both
portal and hepatic veins (PVE/HVE) has been described as a possible superior alternative
to PVE, as it increases and accelerates hypertrophy of the FLR. PVE/HVE combines
simultaneous embolization of the main portal vein branches into the tumor carrying liver
and the hepatic vein draining this part of the liver. Preclinical studies in pigs,
several retrospective studies, and the prospective DRAGON 1 interim analysis (n=60) have
demonstrated the safety and feasibility of this novel technique. However, no
international randomized controlled trial has been performed, in which combined PVE/HVE
is compared with PVE
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationAcademisch Ziekenhuis Maastricht
Principal InvestigatorRonald M. Van Dam
- Primary IDNL80303.068.22
- Secondary IDsNCI-2025-05096
- ClinicalTrials.gov IDNCT05428735