Study of Tumor Changes and Treatment Response in Liver and Bile Duct Cancer Patients Receiving Surgery or Medical Therapy

What this Trial Is About

Researchers are conducting the BILLIONSTARS study, a prospective, single-arm observational trial focused on patients diagnosed with hepatocellular carcinoma HCC or cholangiocarcinoma CCC who are recommended locoregional interventions such as surgery, ablation, or transarterial chemoembolization, andor antitumoral medical treatments. The study aims to understand how tumor characteristics and individual factors influence treatment response by analyzing blood samples, tumor tissue, and other biological markers. The study plans to enroll 150 patients at specific hospitals and includes research autopsies for patients in late palliative phases. Participants will have blood samples collected before, during, and after systemic treatment to analyze circulating tumor DNA, immune cells, and proteins. Tumor tissue from surgical specimens will be collected mainly as formalin-fixed paraffin-embedded samples, with some fresh tissue stored for future research. Quality of life questionnaires will be completed at the start of the study and at three and six months. Treatments will follow national guidelines and will not be influenced by study participation. Radiological and clinical follow-ups will occur as part of usual care or when clinically necessary. During the study, participants will be monitored through blood sample collections aligned with treatment visits and will complete quality of life assessments. The primary outcome measure is overall survival, assessed up to 60 months. Secondary outcomes include progression-free survival and changes in quality of life using specific questionnaires. The study includes safety and clinical follow-up as per standard protocols, with participation lasting up to several years based on survival and treatment timelines.

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