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 range12 Years
SexALL
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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…
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