Study on Combining Immunotherapy and Liver-Directed Treatment for Liver Cancer (HCC)
Sponsor: Ju Dong Yang
ClinicalTrials ID:NCT07489976
This clinical trial is exploring whether a combination of immunotherapy and a liver-targeted procedure can safely and effectively shrink or control liver cancer, potentially making more patients eligible for a liver transplant. The study will also monitor for any side effects from the treatments.
Patient Parameters
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Program Overview
The purpose of this study is to find out if combining immunotherapy with a liver-directed procedure can help shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to lower the cancer stage so more patients might qualify for a liver transplant. Researchers will also watch for any side effects from the treatments. The study will include up to 41 patients.
Description
In this study, patients with intermediate or advanced liver cancer (HCC) will receive a combination of immunotherapy and a liver-directed procedure. The immunotherapy involves medicines called tremelimumab and durvalumab, given through an IV. After the initial treatment, patients may continue receiving durvalumab every four weeks for up to 12 cycles. The liver-directed procedure could be one of several options, such as Yttrium-90 (Y90) radiation, TACE (a type of chemotherapy delivered directly to the liver), or RFA (a heat treatment to destroy the tumor). These procedures are done by specialists using imaging to guide them, and patients may receive medication to help them relax or sleep during the procedure. The U.S. FDA has approved these drugs for use in this study. Researchers will also study a biomarker test to see if it can predict long-term effects of the treatment. A biomarker is a molecule found in blood or tissues that can indicate a disease or how a patient might respond to treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have liver cancer (HCC) confirmed by tests and a life expectancy of at least 12 months.
- Have a liver biopsy confirming HCC within 3 months before starting the study treatment.
- Be in relatively good health with an ECOG performance status of 0 to 2.
- Have liver function classified as Child-Pugh A or B7.
- Have measurable liver cancer that cannot be removed by surgery.
- For those who can have children, a negative pregnancy test and agreement to use contraception during the study and for 3 months after the last dose of durvalumab.
- Provide written informed consent and agree to follow study requirements.
Exclusion Criteria
- Have a rare type of liver cancer or mixed liver and bile duct cancer.
- Have cancer spread to organs outside the liver.
- Have certain types of blood vessel involvement in the liver.
- Have had previous immune therapy treatments.
- Be pregnant, breastfeeding, or planning to become pregnant during the study.
- Have a history of autoimmune diseases.
- Lack interest or support for organ transplantation.
- Have another active or progressing cancer.
- Have certain lung diseases or active lung inflammation.
- Have active tuberculosis or certain viral infections.
- Have had a severe infection recently.
- Have received investigational therapy or certain medications recently.
- Have had recent major surgery or radiation therapy.
- Have any condition that could interfere with the study or increase risk from the treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cedars Sinai | 90048 | Los Angeles | California |
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