Actively Recruiting
Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
Led by University Hospital Tuebingen · Updated on 2026-02-12
20
Participants Needed
2
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Peptide Vaccine for Fibrolamellar Hepatocellular Carcinoma Patients and Other Tumor Entities Carrying the Driver Fusion DNAJB1-PRKACA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent
- Histologically confirmed fibrolamellar hepatocellular carcinoma or other malignant disease with DNAJB1-PRKACA fusion transcript
- Complete remission achieved by surgery, radiotherapy, local therapies (e.g., TACE, SIRT), or systemic treatment
- Age 12 years or older (patients under 18 enrolled only after 6 adults)
- ECOG performance status of 2 or less
- Adequate laboratory values: absolute lymphocyte count > 500/µl, platelets > 50,000/µl, creatinine clearance > 30 ml/min, ALT and AST ≤ 5 times upper limit, bilirubin ≤ 3 mg/dl
- Negative hepatitis B, hepatitis C RNA, and HIV tests within 6 weeks prior to inclusion
- Agreement to use two effective contraception methods for sexually active females of childbearing potential and males with partners of childbearing potential, from consent until 3 months after last vaccination
- Two negative pregnancy tests for females of childbearing potential before first vaccination
- Postmenopausal status or documented non-child-bearing status
- Willingness to minimize blood and body fluid exposure after vaccination, including refraining from sperm or egg donation and blood donation
You will not qualify if you...
- Pregnant or breastfeeding
- Unable or unwilling to follow study schedule
- Treatment within 14 days prior in another interventional anti-cancer trial
- Concurrent treatment with surgery, radiotherapy, local therapies (e.g., TACE, SIRT), or systemic chemotherapy
- Treatment with anti-cancer vaccine within past 6 months
- Live vaccine therapy within 28 days before study treatment
- Known allergy or sensitivity to investigational drug
- Active autoimmune disease requiring systemic treatment in past 2 years or severe autoimmune disease history
- Use of systemic steroids (>10 mg/day) or immunosuppressive agents, except post-liver transplant patients on immunosuppressants
- Uncontrolled illnesses including infection, heart failure, unstable angina, arrhythmia, metastatic cancer, or psychiatric/social issues limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Hospital Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
2
Universitätsklinikum Tübingen, Kinderheilkunde I
Tübingen, Germany, 72076
Not Yet Recruiting
Research Team
J
Juliane Walz, Prof. Dr.
CONTACT
H
Helmut Salih, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here