On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC), Cholangiocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
BILe Duct and LIver Cancer: ON-treatment Surveillance of Tumor Evolution And Response to Systemic Treatment
Overview
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
Detailed description
The BILLIONSTARS study is a prospective, single arm observational study. Patients at Skåne University Hospital in Malmö/Lund and Central Hospital in Kristianstad 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 will be included. A total enrolment of 150 patients is planned.
Before start of treatment, the patients will receive information about the study by a physician and give their written informed consent. Tumor tissue will be obtained from surgical specimens, predominantly from formalin-fixed paraffin embedded (FFPE) tissue, but in some cases, fresh tissue will be obtained at surgery for cryopreservation to enable future preclinical studies. All blood samples will be taken by a dedicated research nurse in conjunction with the treatment visits. Plasma, serum and buffy coat will be isolated from blood samples, following standard fractionation, to enable analyses of circulating tumor DNA (ctDNA), and other biomarkers. Participants will be asked to fill in quality of life questionnaires (EORTC QLQ-C30 and EORTC-QLQ-HCC18/BIL21) at study start, and after three and six months, respectively.
Treatment regimen will follow national guidelines and will not be affected by participation in the study. Radiological and clinical follow ups will be conducted according to clinical protocols or when deemed necessary by the clinician. Primary endpoint is OS, secondary endpoints are progression free survival and change in quality of life (EORTC QLQ-C30+EORTC-QLQ-HCC18/BIL21).
The study will also include research autopsies. Patients are informed and provide their consent for inclusion in this part of the study when they are in a late palliative phase.
Primary outcome measures
- Overall survival [Time frame: From date of inclusion until the date of death from any cause, assessed up to 60 months"]
Secondary outcome measures (4)
- Progression free survival [Time frame: From date of inclusion until the date of first documented progression or death from any cause, whichever comes first, assessed up to 60 months.]
- Impact on quality of life [Time frame: To be filled out at baseline, at three and at six months.]
- Impact on quality of life HCC-specific [Time frame: To be filled out at baseline, at three and at six months.]
- Impact on quality of life BTC-specific [Time frame: To be filled out at baseline, at three and at six months.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 3 centers
- Onkologimottagning Central Hospital in Kristianstad — Kristianstad
- VE Onkologi Skåne University Hospital — Lund
- VO kirurgi och gastroenterologi Skåne University Hospital — Lund
Publications
- Falk P, Olsson Hau S, Jacobsen H, Eberhard J, Williamsson C, Jirstrom K. The bile duct and liver cancer: ON-treatment surveillance of tumor evolution and response to systemic treatment (BILLIONSTARS) study. BMC Cancer. 2025 Jun 11;25(1):1017. doi: 10.1186/s12885-025-14429-w. PMID 40500706
Identifiers
NCT: NCT06877637 · 2024-07592-01