NCT06877637 On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer
| NCT ID | NCT06877637 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-05-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
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
Contact & Investigator
Karin Jirström, PhD, MD, professor
PRINCIPAL INVESTIGATOR
Region Skane
Frequently Asked Questions
Who can join the NCT06877637 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06877637 currently recruiting?
Yes, NCT06877637 is actively recruiting participants. Contact the research team at karin.jirstrom@med.lu.se for enrollment information.
Where is the NCT06877637 trial being conducted?
This trial is being conducted at Kristianstad, Sweden, Lund, Sweden, Lund, Sweden.
Who is sponsoring the NCT06877637 clinical trial?
NCT06877637 is sponsored by Region Skane. The principal investigator is Karin Jirström, PhD, MD, professor at Region Skane. The trial plans to enroll 150 participants.
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