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Hepatocellular Carcinoma (HCC)BILLIONSTARSNCT06877637

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

An observational study of Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, run by Region Skane at 3 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
150 participants
Where
3 sitesSweden
Study dates
15 May 2025to 31 Dec 2029
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients diagnosed with Cholangiocarcinoma or Hepatocellular carcinoma at Skåne University Hospital in Malmö/Lund , Sweden, and at Central Hospital in Kristianstad, Sweden.

Who may be able to join

  • > 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.

Who cannot join

  • < 18 years of age
  • Severe comorbidities
  • Inability to comprehend study information

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Karin Jirström, PhD, MD, professor contact

+46462220829

karin.jirstrom@med.lu.se

Philip Falk, MD contact

+46709221850

philip.falk@med.lu.se

Sweden3 sites, 3 recruiting

  • Onkologimottagning Central Hospital in Kristianstad

    Kristianstad, 29185

    Philip Falk, MD, +4646175625, philip.falk@skane.se

    Recruiting

  • VE Onkologi Skåne University Hospital

    Lund, 22185

    Philip Falk, MD, +4646175625, philip.falk@skane.se

    Jakob Eberhard, MD, PhD, +46171000, jakob.eberhard@skane.se

    Recruiting

  • VO kirurgi och gastroenterologi Skåne University Hospital

    Lund, 22185

    Caroline Williamsson, MD, PhD, +4646171000, Caroline.williamsson@med.lu.se

    Recruiting

Other trials in Sweden

About this study

Official title: BILe Duct and LIver Cancer: ON-treatment Surveillance of Tumor Evolution And Response to Systemic Treatment

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

Read the 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.

Keywords
cholangiocarcinoma, hepatocellular carcinoma, bile duct cancer, liver cell cancer, circulating tumor DNA, targeted therapy, tumor heterogeneity, tumor evolution
Medical subject headings
Carcinoma, Hepatocellular, Cholangiocarcinoma, Bile Duct Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: From date of inclusion until the date of death from any cause, assessed up to 60 months"

Secondary outcomes (4)

  1. Progression free survival

    Measured: From date of inclusion until the date of first documented progression or death from any cause, whichever comes first, assessed up to 60 months.

  2. Impact on quality of life

    Change in quality of life as measured by the form "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer 30 (QLQ-C30). For questions 1-28 the minimum value is 28 and the maximum value is 112, where a higher value indicates worse symptom impact. For questions 29-30 the minimum value is 2 and the maximum value is 14 where a higher value indicates better health status and quality of life.

    Measured: To be filled out at baseline, at three and at six months.

  3. Impact on quality of life HCC-specific

    Change in quality of life as measured by the form "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Hepatocellular Carcinoma 18 (QLQ-HCC18). For the18 questions the minimum value is 18 and the maximum value is 72, where a higher value indicates worse symptom impact.

    Measured: To be filled out at baseline, at three and at six months.

  4. Impact on quality of life BTC-specific

    Change in quality of life as measured by the form "European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Biliary Tract Cancer 18 (QLQ-BIL21). For the 21 questions the minimum value is 21 and the maximum value is 84, where a higher value indicates worse symptom impact.

    Measured: To be filled out at baseline, at three and at six months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start15 May 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06877637
Sponsor's protocol ID
2024-07592-01
Acronym
BILLIONSTARS
Status last verified
Jul 2026
First submitted
25 Feb 2025
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40500706

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, run by Region Skane at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karin Jirström, PhD, MD, professor (+46462220829, karin.jirstrom@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: From date of inclusion until the date of death from any cause, assessed up to 60 months"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06877637, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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