On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer

Sponsor
Region Skane
Study ID
NCT06877637
Status
Recruiting
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Conditions

  • Cholangiocarcinoma
  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The BILLIONSTARS study is a prospective, single arm observational study inviting patients diagnosed with hepatocellular carcinoma (HCC) or cholangiocarcinoma (CCC) who are to be recommended locoregional intervention by surgery, ablation or transarterial chemoembolization and/or antitumoral medical treatment. The aim is to investigate how tumor- and individual-related factors affect response to treatment. To this end, circulating tumor DNA, immune cells and various proteins will be analyzed in repeated blood samples taken before, during and after completion of systemic treatment. When applicable, analyses will also be performed on tumor tissue from resected tumors and biopsies, and in some cases also from autopsies

Key Dates

First listed
Mar 14, 2025
Start date
May 15, 2025
Status verified
May 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
150 participants (estimated)

Primary Outcome Measure

Overall survival [ Time Frame: From date of inclusion until the date of death from any cause, assessed up to 60 months" ]

Central Contacts

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