Blood ctDNA monitoring for hepatocellular carcinoma and colorectal cancer that spread to the liver
A Prospective Randomized Trial Assessing the Impact of ctDNA Testing in Patients After Liver Resection or Transplantation Due to Metastases From Colorectal Cancer or Hepatocellular Carcinoma (HCC) on Treatment Strategies and Long-term Survival"
This trial tests whether a blood test that detects circulating tumor DNA (ctDNA) can track recurrence or progression in adults undergoing liver surgery or transplant for HCC or colorectal cancer with liver-only metastases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT07001085 on ClinicalTrials.gov |
What this trial studies
Participants will have tumor tissue sequenced to identify tumor-specific mutations and will provide serial peripheral blood samples for plasma ctDNA testing. Identified mutations will be followed using ddPCR to detect minimal residual disease (MRD) and changes over time. The study enrolls adults with resectable or transplant-planned HCC and patients with colorectal cancer limited to the liver who are eligible for liver surgery or transplant. Investigators will correlate ctDNA presence and dynamics with imaging, clinical course, and treatment type to see if ctDNA timing predicts recurrence or progression and could inform longer-term outcomes.
Who should consider this trial
Good fit: Adults aged 18–75 with resectable or transplant-planned hepatocellular carcinoma, or adults 18–75 with colorectal cancer limited to the liver after removal of the primary tumor and eligible for liver surgery or transplant, without other active cancers and meeting virological criteria.
Not a fit: Patients under 18 or over 75, those with visible extrahepatic metastases, active excluded viral infections, other concurrent cancers, or chronic immunosuppression outside transplant indications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, ctDNA monitoring could detect recurrence earlier than imaging, allowing earlier treatment decisions and potentially improving long-term outcomes.
How similar studies have performed: Retrospective and observational work in colorectal and several other cancers has shown promising ctDNA MRD signals, but prospectively obtained evidence—especially for HCC—is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-75 years of both sexes; * patients with synchronous or metachronous metastases of colorectal cancer limited to the liver after complete removal of the primary lesion from the intestine qualified for liver resection or transplantation; * or patients with resectable or unresectable HCC scheduled for liver resection or transplantation * no history of other cancers; * negative virological status in the case of mCRC; * In the case of mCRC - patient after any type of liver surgery (staged, ALPPS, multi-site resection) * Patient with or without neoadjuvant chemotherapy compatible with established adjuvant therapy Exclusion Criteria: * age under 18 and over 75; * pregnancy * patients with extrahepatic metastases visible in imaging studies; * metabolic and autoimmune diseases or chronic immunosuppressive treatment other than in the group of patients after liver transplantation due to HCC; * positive virological status, excluding the group of patients with HCC; * history of other cancer; * Chronic steroid therapy and diagnosed active autoimmune diseases * Patient after radiotherapy * Patient participating in other clinical trials of oncological and non-oncological drugs * Patients legally incapacitated
Where this trial is running
Warsaw, Masovian Voivodeship
- Medical University of Warsaw — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Tomasz Stokłosa, Professor — tomasz.stoklosa@wum.edu.pl
- Study coordinator: Izabela Górzyńska, Associate Professor
- Email: oskar.kornasiewicz@gmail.com
- Phone: 22 599 25 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.