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New vaccine targets rare liver cancer's genetic flaw

NCT ID NCT06789198

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This early-stage trial tests a personalized peptide vaccine for people with a rare liver cancer called fibrolamellar hepatocellular carcinoma (FLC) or other tumors that share a specific genetic change (DNAJB1-PRKACA fusion). The vaccine is designed to train the body's immune cells to recognize and attack cancer cells carrying this fusion. The study will enroll about 20 participants who have achieved complete remission after standard treatments, to see if the vaccine is safe and triggers a strong immune response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Criteria: * Pregnant or breastfeeding. * Unwilling or unable to follow the study schedule for any reason. * 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. * Any live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment * Known sensitivity to or history of allergic reactions to investigational drug. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital Tuebingen

    RECRUITING

    Tübingen, 72076, Germany

  • Universitätsklinikum Tübingen, Kinderheilkunde I

    RECRUITING

    Tübingen, 72076, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.