Clinical trial · Observational
On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer
BILe Duct and LIver Cancer: ON-treatment Surveillance of Tumor Evolution And Response to Systemic Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From date of inclusion until the date of death from any cause, assessed up to 60 months"
Secondary outcomes (4)
- measure
- Progression free survival
- timeFrame
- From date of inclusion until the date of first documented progression or death from any cause, whichever comes first, assessed up to 60 months.
- measure
- Impact on quality of life
- timeFrame
- To be filled out at baseline, at three and at six months.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDFalk 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