Actively Recruiting
Phase II Study of Autologous Dendritic Cell Vaccine Combined with Immune Checkpoint Inhibition After High-Dose Radiation in Unresectable Primary Liver Cancer
Led by Mayo Clinic · Updated on 2026-04-20
85
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the side effects and potential benefits of using patients' own dendritic immune cells combined with a pneumonia vaccine called Prevnar and immune checkpoint inhibitors in treating unresectable liver cancer after high-dose external beam radiotherapy. This trial includes patients with hepatocellular carcinoma and intrahepatic cholangiocarcinoma that cannot be removed by surgery. The study aims to evaluate safety, tolerability, progression-free survival, and immune response in this patient population. Participants undergo standard high-dose external beam radiation therapy over 1 to 3 weeks, followed by cycles of intratumoral injections of autologous dendritic cells and intramuscular Prevnar vaccine during treatment cycles. Groups also receive intravenous immune checkpoint inhibitors such as atezolizumab with bevacizumab or durvalumab, depending on the cancer type. Treatment cycles repeat every 21 or 28 days for up to 7 cycles unless disease progression or unacceptable side effects occur. During the study, participants have various assessments including imaging scans (CT, PET/CT, MRI), biopsies, blood and urine sample collections, and esophagogastroduodenoscopy at screening. After treatment, patients are monitored regularly with follow-up visits every 3 months for a year, then continued monitoring until disease progression and up to 5 years after enrollment. Researchers measure toxicity, tumor response, survival rates, and immune system activity throughout the study.
CONDITIONS
Brief 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 unresectable hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (iCCA)
- Measurable or evaluable liver tumor accessible for ultrasound-guided dendritic cell injection
- No evidence of extrahepatic tumor except tumor thrombus
- Suitable candidate for high-dose conformal external beam radiation therapy (EBRT)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Specific blood count and liver function criteria met within 15 days prior to registration for HCC and iCCA groups
- Ability to provide written consent
- Willingness to return for follow-up and provide blood and tissue samples
You will not qualify if you...
- Pregnant or nursing persons, or persons unwilling to use effective contraception during and 5 months after study
- Severe concurrent disease or systemic illnesses interfering with study participation
- Immunocompromised patients or known HIV positive with unstable condition
- Active infection requiring systemic treatment or severe infection within 4 weeks prior to registration
- Significant cardiovascular disease or psychiatric illness limiting compliance
- Receiving other investigational agents for primary cancer
- Other active malignancies within 1 year interfering with treatment or outcomes
- Major surgery within 4 weeks prior to enrollment except diagnostic or spacer placement
- History of severe allergic reaction to pneumococcal vaccine components
- Active or history of autoimmune diseases except well-controlled mild skin or thyroid conditions
- Need for anticoagulant or anti-platelet agents that cannot be stopped for injection procedure
- Recent corticosteroid use with exceptions
- History of heart attack within 6 months or life-threatening heart arrhythmias
- Child Pugh class B or C liver cirrhosis
- Previous immune modulating therapies including checkpoint inhibitors or dendritic cell therapy
- Prior liver radiation including radioembolization
- Advanced liver cancer stage or untreated high-risk varices (HCC group only)
- Active tuberculosis or recent therapeutic antibiotic treatment
- Prior allogeneic stem cell or organ transplant
- Recent live attenuated vaccine within 4 weeks prior to registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including esophagogastroduodenoscopy (EGD) for some participants
Duration - 1 to 3 weeks
Participants undergo apheresis for dendritic cell manufacturing and receive high-dose external beam radiation therapy (EBRT) over 1 to 3 weeks.
Approximately 5 to 15 radiation therapy sessions
Duration - Up to 7 cycles of 21 or 28 days each
Participants receive intratumoral injections of autologous dendritic cells and pneumococcal vaccine intramuscularly during the first 4 cycles. Participants in some groups also receive intravenous immune checkpoint inhibitors and other biological therapies. Treatment cycles repeat every 21 or 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.
Up to 7 visits per cycle including intratumoral dendritic cell injections and intravenous infusions; additional pneumococcal vaccine injections during first 4 cycles
Duration - Up to 5 years
After treatment completion, participants have follow-up visits starting 2 weeks post-treatment, then every 3 months for 1 year, followed by visits every 3 months until disease progression, and then every 6 months up to 5 years after registration to monitor health and disease status.
Visits every 3 months for 1 year, then every 3 months until progression, then every 6 months until 5 years post-registration
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
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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