Clinical Trial 24386

• Overview

  Study Title:

  DRAGON 2 - 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).

  Summary:

  There are several techniques for growing the future residual liver. Growing the residual liver is necessary in cases to undergo surgery to remove the cancer in the liver. In this study, investigators want to compare a new technique (combined Portal and Liver vein embolization) with current standard care (Portal vein embolization only). The aim of this study is to find out whether this new technique is better than the original technique

  Objective:

  Primary Objectives: * To investigate the effect of combined PVE/HVE compared to PVE alone on: 1. the resectability of the patients within 3 weeks after intervention defined as FLR sufficient for resection on week 3 and 2. the 5-year overall survival. Secondary Objectives: * Weekly kinetic growth rate and volume of the FLR (efficacy assessment) * FLR function increase (Hepatobiliary scintigraphy, MRI-function) * The success rate of IR procedure (embolization) performed as scheduled * Time to sufficient FLR volume * Salvage procedures after PVE or combined PVE/HVE * Post-embolization complications prior to surgery * Time from intervention to resection * Clinical resectability * Operation time * Intraoperative complications * Intraoperative blood loss * Liver inflammation, fibrosis and cirrhosis at histology * Cancer type and mutations at histology * Number of postoperative complications/AE until 90 days post-surgery * Rate of PHLF * Mortality at 90 days * Radiological resectability and 90-day survival * Composite of clinical resectability and 90 day survival. * Survival at 3 years * Recurrence rate * Progression-free survival at 3 years * Recurrence location * Number and type of oncological interventions (for example repeat resections, ablations, selective internal radiation therapy (SIRT), Systemic therapy, etcetera) during survival * Reason for oncological intervention or best supportive care for all recurrences within 5 years * Cause of death * Quality of life (QoL) * Costs

• Inclusion Criteria

  Inclusion Criteria:
  • Patients with primarily unresectable/ potentially resectable CRLM with a FLR > 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

  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.

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