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

Phase

N/A

Condition

Abdominal Cancer

Digestive System Neoplasms

Biliary Tract Cancer

Treatment

N/A

Clinical Study ID

NCT06877637

2024-07592-01

Ages > 18
All Genders

Study 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

Inclusion Criteria:

> 18 years of age
Clinically diagnosed intrahepatic Cholangiocarcinoma (iCCC), perihilarCholangiocarcinoma (pCCC), distal Cholangiocarcinoma (dCCC), gall bladder carcinoma (GBC) or mixed Hepatocellular carcinoma/Cholangiocarcinoma planned to undergosurgery
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 ortransarterial chemo-embolization. For patients planned to receive systemic treatmenthistological or cytological confirmation is required except for patients withLI-RADS 5 lesions.

Exclusion

Exclusion Criteria:

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

Study Design

May 15, 2025

December 31, 2029

Study 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.

Connect with a study center

Onkologimottagning Central Hospital in Kristianstad
Kristianstad, 29185
Sweden
Active - Recruiting
VE Onkologi Skåne University Hospital
Lund, 22185
Sweden
Active - Recruiting
VO kirurgi och gastroenterologi Skåne University Hospital
Lund, 22185
Sweden
Site Not Available

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