Monitoring tumor changes and treatment response in bile duct and liver cancer patients
BILe Duct and LIver Cancer: ON-treatment Surveillance of Tumor Evolution And Response to Systemic Treatment
This study is testing how different factors affect treatment responses in people with bile duct or liver cancer by looking at their blood and tumor samples during and after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 3 sites (Kristianstad and 2 other locations) |
| Trial ID | NCT06877637 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with intrahepatic or extrahepatic cholangiocarcinoma or hepatocellular carcinoma who are recommended for locoregional intervention.
Not a fit: Patients under 18 years old or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of treatment responses and personalized approaches for patients with bile duct and liver cancers.
How similar studies have performed: While this study employs a novel approach to monitoring treatment response, similar studies have shown promise in utilizing circulating tumor DNA for tracking cancer evolution.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kristianstad and 2 other locations
- 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 (Not_yet_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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.