Monitoring tumor changes and treatment response in bile duct and liver 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 BILLIONSTARS study is a prospective observational study that aims to understand how individual and tumor-related factors influence treatment responses in patients diagnosed with hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC). Participants will undergo locoregional interventions such as surgery, ablation, or transarterial chemoembolization, and their blood samples will be analyzed for circulating tumor DNA and other biomarkers before, during, and after treatment. Additionally, tumor tissue may be collected for further analysis, and patients will complete quality of life questionnaires at various intervals throughout the study. A total of 150 patients will be enrolled at Skåne University Hospital and Central Hospital in Kristianstad.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \> 18 years of age
* Clinically diagnosed intrahepatic Cholangiocarcinoma (iCCC), perihilar Cholangiocarcinoma (pCCC), distal Cholangiocarcinoma (dCCC), gall bladder carcinoma (GBC) or mixed Hepatocellular carcinoma/Cholangiocarcinoma planned to undergo surgery
* Histologically or cytologically confirmed Cholangiocarcinoma (iCCC, pCCC, dCCC, GBC, mixed HCC/CCC) for patients planned to receive palliative systemic treatment or
* Clinically diagnosed Hepatocellular carcinoma (HCC) planned for surgery, ablation or transarterial chemo-embolization. For patients planned to receive systemic treatment histological or cytological confirmation is required except for patients with LI-RADS 5 lesions.

Exclusion Criteria:

* \< 18 years of age
* Severe comorbidities
* Inability to comprehend study information

Where it's running

• Onkologimottagning Central Hospital in Kristianstad
  Kristianstad, Sweden Recruiting
• VE Onkologi Skåne University Hospital
  Lund, Sweden Recruiting
• VO kirurgi och gastroenterologi Skåne University Hospital
  Lund, Sweden Recruiting

Study contacts

• Principal investigator: Karin Jirström, PhD, MD, professor — Region Skane
• Study coordinator: Karin Jirström, PhD, MD, professor
• Email: karin.jirstrom@med.lu.se
• Phone: +46462220829

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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.