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Immunotherapy + Vaccine for Liver Cancer
Phase 1 & 2
Recruiting
Led By Lewis R. Roberts, M.D., Ph.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Phase II study (group 2): Histological and/or radiologic confirmation of hepatocellular carcinoma (HCC)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses the patient's own immune cells to fight the cancer.
Who is the study for?
This trial is for adults with liver cancer that can't be removed by surgery. They must have a certain level of white blood cells, kidney function, and liver function, and not be pregnant or nursing. People with other active cancers, recent major surgeries, severe allergies to vaccines, HIV on antiretroviral therapy, serious illnesses that could affect the study results or who are taking certain medications are excluded.Check my eligibility
What is being tested?
The trial tests if modified immune cells (autologous dendritic cells) from patients' own blood can stimulate the immune system to fight liver cancer when given after high-dose radiation therapy. It also examines whether adding Prevnar vaccine enhances this effect. The safety and effectiveness of combining these treatments with immune checkpoint inhibitors will be studied in two phases for different types of liver cancer.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site where modified immune cells are administered, flu-like symptoms due to immune response stimulation by the vaccine and treatment-related inflammation affecting various organs due to checkpoint inhibitors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer has been confirmed by tests and scans.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is confirmed as intrahepatic cholangiocarcinoma.
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My scans show no cancer outside the liver.
Select...
My cancer can be measured or seen on tests.
Select...
My liver cancer cannot be removed by surgery.
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All my cancer lesions can be targeted with external beam radiation without harming healthy tissues.
Select...
My tumor can be reached with a needle for treatment under ultrasound guidance.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of significant toxicity (Pilot study)
Progression-free survival rate at 2 years (Phase II)
Secondary outcome measures
Clinical benefit rate
Duration of response
Number of patients who received at least one dose of intratumoral DC injection
+4 moreOther outcome measures
Change in immunologic correlates before and after vaccination treatment
Change in target lesion measurements
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pilot study (pheresis, EBRT, dendritic cells, Prevnar)Experimental Treatment4 Interventions
Patients with unresectable intrahepatic CCA undergo apheresis for dendric cell manufacturing and standard of care high-dose EBRT for 5 or 15 fractions over 1-3 weeks (cycle 1). Patients then receive autologous dendritic cells IT on day 1 of cycles 2-8 and pneumococcal 13-valent conjugate vaccine IM on day 1 of cycles 2-4 only. Treatment repeats every 28 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Phase II(pheresis, EBRT, dendritic cells, Prevnar, atezo, bev)Experimental Treatment6 Interventions
Patients with unresectable HCC undergo apheresis for dendric cell manufacturing and standard of care high-dose EBRT for 5 or 15 fractions over 1-3 weeks (cycle 1). Patients then receive autologous dendritic cells IT on day 1 of cycles 2-8 and pneumococcal 13-valent conjugate vaccine IM on day 1 of cycles 2-4 only. Patients also receive standard of care atezolizumab IV and bevacizumab IV starting on day 2 of cycles 2-8. Treatment repeats every 21 days for up to 7 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Bevacizumab
2013
Completed Phase 4
~5280
Atezolizumab
2017
Completed Phase 3
~5860
Pneumococcal 13-valent Conjugate Vaccine
2019
Completed Phase 4
~4440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,467 Total Patients Enrolled
4 Trials studying Intrahepatic Cholangiocarcinoma
1,157 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,086 Total Patients Enrolled
Lewis R. Roberts, M.D., Ph.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My urine protein levels are low enough for the trial.My liver cancer is in the most advanced stage.My liver cancer has been confirmed by tests and scans.My liver disease is moderately to severely advanced.If you have HIV but are otherwise healthy, you can still participate in this trial.I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 3 years.My doctor thinks I'm a good fit for a specific type of radiation therapy.I have not had major surgery within the last 4 weeks, except for diagnostic procedures or to prepare for radiation.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is confirmed as intrahepatic cholangiocarcinoma.I have an active autoimmune disease like rheumatoid arthritis or lupus.I have had treatments that boost the immune system, like drugs targeting PD-1 or CTLA4.I am using heparin for my IV line, but my blood clotting tests are normal.I am not a candidate for surgery or curative ablation.My scans show no cancer outside the liver.I have a history of cancer but am not currently receiving treatment for it.My cancer can be measured or seen on tests.I need treatment for blood clotting issues or take blood thinners that can't be stopped for a cancer injection procedure.I haven't taken any form of corticosteroids in the last 2 weeks.I take less than 10 mg/day of prednisone for a chronic condition.My liver cancer cannot be removed by surgery.All my cancer lesions can be targeted with external beam radiation without harming healthy tissues.My tumor can be reached with a needle for treatment under ultrasound guidance.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I understand the study drug's effects on unborn babies are unknown.I have had a heart attack in the last 6 months or have heart failure needing constant treatment.I am immunocompromised or HIV positive and on antiretroviral therapy.I am 18 years old or older.I have had radiation treatment for my liver.You are currently taking any experimental medication for your main cancer.I have untreated high-risk varices in my stomach or esophagus.You are willing to give blood and tissue samples for research purposes.
Research Study Groups:
This trial has the following groups:- Group 1: Pilot study (pheresis, EBRT, dendritic cells, Prevnar)
- Group 2: Phase II(pheresis, EBRT, dendritic cells, Prevnar, atezo, bev)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what end is Pneumococcal 13-valent Conjugate Vaccine typically applied?
"Pneumococcal 13-valent Conjugate Vaccine is frequently utilized to treat tetanus, but it can also be beneficial for combatting pneumococcal infections, traumatic injuries, and diphtheria."
Answered by AI
Is enrollment for this medical research still available to participants?
"The current recruitment status of this clinical trial, which was initially posted on May 17th 2019 and revised June 1st 2022, is available through clinicialtrials.gov."
Answered by AI
What is the scope of recruitment for this research project?
"Affirmative. The clinicaltrials.gov platform indicates that this research project, which was posted on May 17th 2019, is currently open for enrollment. This trial seeks to welcome 26 volunteers from a single medical site."
Answered by AI
Are there any prior investigations concerning Pneumococcal 13-valent Conjugate Vaccine?
"At present, there are 21 studies focused on the Pneumococcal 13-valent Conjugate Vaccine. Of these active trials, 5 have reached Phase 3 and numerous sites - 321 to be exact - in Alken, Florida alone are running their own assessments for this vaccine's efficacy."
Answered by AI
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