Actively Recruiting
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Led by Mayo Clinic · Updated on 2026-04-20
85
Participants Needed
1
Research Sites
519 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.
CONDITIONS
Official Title
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologic and/or radiologic confirmation of hepatocellular carcinoma or intrahepatic cholangiocarcinoma
- Unresectable disease with measurable or evaluable tumor lesions treatable by EBRT
- Tumor lesions accessible for ultrasound-guided intratumoral dendritic cell injection
- No evidence of extrahepatic tumor (except tumor thrombus) by CT or MRI
- Good candidate for high-dose conformal EBRT as determined by investigator
- ECOG performance status 0 or 1
- Specific blood count and liver function criteria met within 15 days prior to registration for each group
- Ability to provide written consent
- Willingness to return for follow-up visits and provide blood and tissue samples for research
You will not qualify if you...
- Pregnant or nursing persons, or those unwilling to use effective contraception during and 5 months after treatment
- Severe systemic illnesses or diseases interfering with treatment or safety assessment
- Immunocompromised patients or unstable HIV positive status
- Uncontrolled active infections or severe infections within 4 weeks prior to registration
- Significant cardiovascular disease or psychiatric/social conditions limiting compliance
- Receiving other investigational treatments for primary cancer
- Other active malignancy within 1 year that interferes with treatment or outcome measurement
- Major surgery within 4 weeks prior to enrollment or planned major surgery during study
- History of severe allergic reactions to pneumococcal vaccine or its components
- Active or history of autoimmune or immune deficiency diseases, with some exceptions
- Use of anticoagulants or anti-platelet agents that cannot be stopped for injection procedure
- Corticosteroid use within 2 weeks prior to registration beyond allowed exceptions
- Recent myocardial infarction or severe heart conditions
- Child Pugh class B or C liver cirrhosis
- Prior immune modulating therapies or liver radiation
- For HCC group: advanced liver cancer stage or untreated high-risk varices
- Active tuberculosis or recent therapeutic antibiotic treatment except prophylaxis
- Prior allogeneic stem cell or solid organ transplant
- Live attenuated vaccine within 4 weeks prior to registration
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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