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

Recruitingn/aAges 18 Years - anyAllRegion Skane
NCT06877637 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

3 sites
Onkologimottagning Central Hospital in Kristianstad
Kristianstad, Sweden
VE Onkologi Skåne University Hospital
Lund, Sweden
VO kirurgi och gastroenterologi Skåne University Hospital
Lund, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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