Comparing two methods to induce liver regeneration in colorectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DRAGON 2 trial is a randomized controlled trial that compares two approaches for inducing liver regeneration in patients with colorectal cancer liver metastases (CRLM) who have a small future liver remnant (FLR). Participants will be assigned to either the control group receiving portal vein embolization (PVE) alone or the interventional group receiving combined portal and hepatic vein embolization (PVE/HVE). The goal is to determine if the combined approach leads to better liver hypertrophy and reduces the risk of post-hepatectomy liver failure. This study builds on previous findings suggesting that PVE/HVE may be a superior method for enhancing liver regeneration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Monash Medical Centre
  Clayton, Victoria, Australia Recruiting
• Hôpital Erasme
  Brussels, Brussels Capital, Belgium Recruiting
• CHU de Liège
  Liège, Liège, Belgium Recruiting
• CHU-UCL Namur site Godinne
  Yvoir, Namen, Belgium Recruiting
• UZ Gent
  Ghent, Oost-Vlaanderen, Belgium Recruiting

Study contacts

• Principal investigator: Ronald M. van Dam, PhD — Maastricht Universitair Medisch Centrum
• Study coordinator: Sinéad James, MD, PhD-candidate
• Email: sinead.james@mumc.nl
• Phone: +31 638463945

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ctDNA methylation-guided adjuvant therapy after removing colorectal liver metastases

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• AK104 plus radiotherapy with standard first-line treatment for pMMR/MSS colorectal cancer liver metastases

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• AI-based prediction of liver metastasis after colorectal cancer surgery

  This project will try a deep learning model that combines CT scans, digitized pathology slides, and routine clinical data to predict which stage I–III colorectal cancer patients are likely to develop liver metastases after curative surgery.

  Recruiting Tongji Hospital · Wuhan, Hubei · NCT07399236

• Blood test using exosome microRNAs to find extrahepatic spread in colorectal cancer with liver metastases

  This project will test whether a blood test measuring exosome microRNAs can detect extrahepatic metastases in adults whose colorectal cancer has spread to the liver.

  Recruiting City of Hope Medical Center · Duarte, California · NCT07224724

• Detecting tumor DNA in small automated capillary blood samples from adults with colorectal cancer liver metastases.

  This project will try whether tiny automated capillary (finger‑prick) blood samples can detect circulating tumor DNA in adults with colorectal cancer that has spread to the liver.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT07310537

• Computer-aided tool to predict outcomes after simultaneous colorectal and liver surgery

  This project will test a web-based computer tool that helps doctors predict 1-, 3-, and 5-year recurrence and survival for adults with colorectal cancer who had liver metastases removed at the same time as their primary tumor.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07027605

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.