Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carr… (NCT06789198) | Clinical Trial Compass
RecruitingPhase 1
Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
Germany20 participantsStarted 2025-07-08
Plain-language summary
The aim of this clinical trial is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a DNAJB1-PRKACA fusion transcript-based peptide vaccine (Fusion-VAC-XS15) in patients with FL-HCC or other cancer entities carrying the DNAJB1-PRKACA fusion transcript as adjuvant treatment
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability to understand and willingness to sign a written informed consent document.
* Histologically confirmed Fibrolamellar hepatocellular carcinoma (FL-HCC) or other malignant disease in an adjuvant setting, defined as:
* Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-based NGS or RT-PCR
* Achievement of complete remission (CR) according to RECIST1.1 by any of the following therapeutic measures:
* surgical procedures,
* radiotherapy,
* local therapeutic measures (e.g. TACE, SIRT, etc.)
* systemic treatment (e.g. chemotherapy)
* Age ≥ 12 years. Note: Subjects aged ≥ 12 years but \< 18 are eligible to enroll only after 6 adult patients have been enrolled in the study.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Adequate laboratory values for
* Absolute Lymphocyte Count \> 500 /µl
* Platelets \> 50.000 /µl
* Creatinine clearance GFR \> 30 ml/min
* Alanine aminotransferase (ALT) and aminotransferase (AST) ≤ 5 times upper limit range
* Bilirubin ≤ 3 mg/dl
* Negative serological hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of hepatitis C RNA, negative HIV test within 6 weeks prior to study inclusion.
* Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential who are sexually active must agree to the use of two effective forms (at least one highly effective method) of con…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of vaccination
Timeframe: until 84 days after second vaccination
2
Safety of the vaccination
Timeframe: from first vaccination until 12 months after last vaccination