Study on Using Modified Immune Cells and a Vaccine After Radiation Therapy for Treating Unremovable Liver Cancer
Sponsor: Mayo Clinic
ClinicalTrials ID:NCT03942328
This clinical trial is exploring a new treatment approach for liver cancer that cannot be surgically removed. It involves using a patient's own modified immune cells and a pneumonia vaccine after high-dose radiation therapy to see if this combination can safely stimulate the immune system to fight the cancer.
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Program Overview
This study is testing a new treatment for liver cancer that cannot be removed by surgery. The treatment uses a patient's own immune cells, called dendritic cells, which are modified in a lab to help the immune system attack cancer cells. A pneumonia vaccine, Prevnar, is also used to boost the immune response. The study aims to see if this approach is safe and effective in helping the body fight liver cancer after radiation therapy. The first part of the study focuses on a type of liver cancer called intrahepatic cholangiocarcinoma, while the second part focuses on hepatocellular carcinoma.
Description
The study is divided into two phases:
Phase I: This phase focuses on patients with a type of liver cancer called intrahepatic cholangiocarcinoma. The main goal is to evaluate the safety and tolerability of using modified dendritic cells injected directly into the tumor after high-dose radiation therapy.
Phase II: This phase involves patients with hepatocellular carcinoma. It aims to assess the safety and effectiveness of combining the dendritic cell injections with two other drugs, atezolizumab and bevacizumab, after radiation therapy.
Secondary Goals:
- To see how feasible it is to use this treatment approach.
- To measure how well the cancer responds to the treatment.
- To track how long patients remain free of cancer progression.
- To evaluate the overall survival of patients receiving this treatment.
Study Procedures:
- Patients will undergo a procedure to collect white blood cells for creating the dendritic cells.
- They will receive high-dose radiation therapy over 1-3 weeks.
- Modified dendritic cells will be injected into the tumor, and the Prevnar vaccine will be given to help stimulate the immune system.
- In Phase II, patients will also receive atezolizumab and bevacizumab intravenously.
- Treatment cycles repeat every 21-28 days for up to 7 cycles, depending on the phase.
After completing the treatment, patients will have follow-up visits to monitor their health and the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- For Phase I: Must have intrahepatic cholangiocarcinoma.
- For Phase II: Must have hepatocellular carcinoma.
- Cancer must be unremovable by surgery and measurable.
- Tumors must be treatable with radiation and accessible for dendritic cell injection.
- No cancer outside the liver, except for certain conditions.
- Must be a good candidate for high-dose radiation therapy.
- Must have good overall health and specific blood counts.
- Must not be pregnant and agree to use contraception if of childbearing potential.
- Must be willing to provide blood and tissue samples for research.
Exclusion Criteria
- Cannot be pregnant or breastfeeding.
- Cannot have severe illnesses or conditions that would interfere with the study.
- Cannot be immunocompromised or have active infections.
- Cannot have other active cancers within the last 3 years, except for certain types.
- Cannot have had major surgery recently.
- Cannot have allergies to the pneumonia vaccine.
- Cannot have active autoimmune diseases.
- Cannot be on certain medications that affect blood clotting or the immune system.
- Cannot have had recent heart problems or severe liver disease.
- Cannot have received certain immune therapies or liver radiation before.
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