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Search / Trial NCT06877637

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

Launched by REGION SKANE · Mar 11, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cholangiocarcinoma Hepatocellular Carcinoma Bile Duct Cancer Liver Cell Cancer Circulating Tumor Dna Targeted Therapy Tumor Heterogeneity Tumor Evolution

ClinConnect Summary

The BILLIONSTARS study is a research trial aimed at understanding how certain factors influence the response to treatment in patients with bile duct cancer (cholangiocarcinoma) and liver cancer (hepatocellular carcinoma). If you are an adult (18 years or older) who has been diagnosed with one of these cancers and are planning to undergo treatment such as surgery or other medical therapies, you might be eligible to participate. The study will involve taking blood samples at different times during your treatment to look at genetic material from the tumor, immune cells, and proteins, which may help researchers learn more about how these cancers behave and respond to treatments.

As a participant, you will be closely monitored throughout your treatment. This means your health will be checked regularly, and samples will be collected before, during, and after your treatment to gather important information. The study is not yet recruiting participants, so you won't be able to join right away, but it could provide valuable insights that may benefit future patients facing similar challenges.

Gender

ALL

Eligibility criteria

  • 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

About Region Skane

Region Skåne is a leading healthcare authority in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and patients, Region Skåne aims to enhance the understanding of various health conditions and develop effective treatment strategies. With a focus on ethical standards and patient safety, the organization plays a pivotal role in shaping the future of healthcare in the region and beyond, ensuring that clinical trials are conducted with the highest level of scientific rigor and transparency.

Locations

Kristianstad, , Sweden

Lund, , Sweden

Lund, , Sweden

Patients applied

0 patients applied

Trial Officials

Karin Jirström, PhD, MD, professor

Principal Investigator

Region Skåne

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported