Peptide Vaccine Tested Against Fibrolamellar Liver Cancer With a Specific Gene Fusion
Tests a peptide vaccine in patients with fibrolamellar liver cancer after surgery.
Plain-language title generated from the registry record
Registry title: Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
Key facts
- Where
- Tübingen, GermanySee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 or older with fibrolamellar liver cancer, or another cancer with the DNAJB1-PRKACA fusion transcript, who are in complete remission after earlier treatment.
- Age
- 12 years or older. People under 18 must weigh at least 40 kg (88 lb).
- Sex
- All sexes can join.
- Disease stage
- Fibrolamellar hepatocellular carcinoma (FL-HCC) or another cancer, in complete remission (CR) according to RECIST1.1 after surgery, radiotherapy, local treatment or systemic treatment such as chemotherapy. The vaccine is given as an adjuvant treatment.
- Earlier treatment
- Complete remission must have been reached by surgery, radiotherapy, local treatment (for example TACE, SIRT) or systemic treatment (for example chemotherapy). No anti-cancer vaccine within 6 months. No investigational anti-cancer treatment within 14 days.
- Biomarker or test result
- The DNAJB1-PRKACA fusion transcript must be found by RNA-based NGS or RT-PCR.
Main reasons for not taking part
- Pregnant or breastfeeding
- Currently having surgery, radiotherapy, local treatment or systemic treatment such as chemotherapy
- Any live vaccine against infections within 28 days
- Active autoimmune disease needing systemic treatment in the past 2 years, or needing systemic steroids (> 10 mg per day) or immunosuppressive drugs (after a liver transplant these drugs are allowed)
- Known allergy to the investigational drug
Read by machine on 12 November 2026.
Where in Germany
- Universitätsklinikum Tübingen, Kinderheilkunde ITübingen, GermanyContact: Juliane Walz, Prof.Dr.Taking people
- University Hospital TuebingenTübingen, GermanyContact: Helmut Salih, Prof. Dr.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital Tuebingen
- Trial code
- NCT06789198EU 2024-519387-41-00
- Record updated
- 14 September 2026
- Original description
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 treatmentRead full original descriptionShow less
FusionVAC22_02: DNAJB1-PRKACA Fusion Transcript-based Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Oncogenic Driver Fusion
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
Inclusion: 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 now because 6 adult patients have been enrolled in the study; Patients <18 years must have a body weight ≥ 40 kg; 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 contraception. This should be started from the signing of the informed consent and be continued until 3 months (both female and male patients) after last dose of the vaccination; For FCBP two negative pregnancy tests (sensitivity of at least 25 mIU/mL) prior to first application of the study drug (vaccination at visit V1), one at screening and the other one at visit V1 prior (< 24h) to first vaccination; Postmenopausal or evidence of non-child-bearing status; Be willing to minimize blood and body fluid exposure after vaccination until end of study; Refrain from sperm or ovary egg donation; Refrain from blood donation.
Exclusion: Concurrent or previous treatment within 14 days in another interventional clinical trial with an investigational anti-cancer treatment; Concurrent treatment with any of the following therapeutic measures:; surgical procedures,; radiotherapy,; local therapeutic measures (e.g. TACE, SIRT, etc.); systemic treatment (e.g. chemotherapy); Concurrent or previous treatment within 6 months with an anti-cancer vaccine treatment; Known sensitivity to or history of allergic reactions to investigational drug; Any live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment; Active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids (> 10 mg per day) or immunosuppressive agents (Please note, patients after liver transplantation requiring immunosupressants are allowed); Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements; Pregnant or breastfeeding; Unwilling or unable to follow the study schedule for any reason.