On-treatment Surveillance of Tumor Evolution and Response to Systemic Treatment in Bile Duct and Liver Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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
This trial does not accept healthy volunteersQualifiers
> 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.
Disqualifiers
< 18 years of age
Severe comorbidities
Inability to comprehend study information
Trial population
Adult patients diagnosed with Cholangiocarcinoma or Hepatocellular carcinoma at Skåne University Hospital in Malmö/Lund , Sweden, and at Central Hospital in Kristianstad, Sweden.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall survival
Time frame
From date of inclusion until the date of death from any cause, assessed up to 60 months"Secondary outcomes
1
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.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.
Time frame
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.
Time frame
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.
Time frame
To be filled out at baseline, at three and at six months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov