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

NCT06877637 | Recruiting

• 1 other identifier: 2024-07592-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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

Conditions

Hepatocellular Carcinoma (HCC); Cholangiocarcinoma

Keywords

cholangiocarcinoma; hepatocellular carcinoma; bile duct cancer; liver cell cancer; circulating tumor DNA; targeted therapy; tumor heterogeneity; tumor evolution

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

Secondary Outcomes (4)

• Progression free survival

  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

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

• Impact on quality of life HCC-specific

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

• Impact on quality of life BTC-specific

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \> 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.

You may not qualify if:

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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (3)

Onkologimottagning Central Hospital in Kristianstad

Kristianstad, 29185, Sweden

RECRUITING

VE Onkologi Skåne University Hospital

Lund, 22185, Sweden

RECRUITING

VO kirurgi och gastroenterologi Skåne University Hospital

Lund, 22185, Sweden

NOT YET RECRUITING

Related Publications (1)

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue will be obtained from surgical specimens and biopsies, 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. 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.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Cholangiocarcinoma; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Karin Jirström, PhD, MD, professor

  Region Skåne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Jirström, PhD, MD, professor

CONTACT

+46462220829; karin.jirstrom@med.lu.se

Philip Falk, MD

CONTACT

+46709221850; philip.falk@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 14, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)