Immunotherapy for Liver Cancer Before Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a combination of immunotherapy drugs, Durvalumab (Imfinzi) and Tremelimumab, can effectively control liver cancer and prepare patients for a liver transplant. The treatment aims to shrink the cancer and maintain control, improving outcomes for those with hepatocellular carcinoma (HCC), a type of liver cancer. Patients may qualify if they have liver cancer confined to the liver, have not received previous treatment for HCC, and are already evaluated and listed for a liver transplant. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in liver cancer treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use immunosuppressive medications within 14 days before starting the trial drugs, except for certain types like inhaled or topical steroids. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of durvalumab and tremelimumab has been tested for safety in people with liver cancer. In one study, most patients tolerated the treatment well, but about 19% experienced liver damage, which could lead to serious issues like tumor growth or even death.
Other studies confirm that while the treatment can be effective, patients should be aware of possible side effects. These may include immune system-related problems because both durvalumab and tremelimumab are immunotherapy drugs that help the body's immune system fight cancer.
Overall, the safety information indicates that although there are risks, many patients manage the treatment well. It's important for anyone considering this option to consult with their healthcare provider to see how it fits their specific needs.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Durvalumab and Tremelimumab for liver cancer because these treatments harness the power of the immune system to fight cancer cells. Unlike traditional treatments like chemotherapy or targeted therapy, which directly attack cancer cells, these drugs are immune checkpoint inhibitors that help the body's immune cells recognize and destroy cancer more effectively. This combination could potentially offer a more robust and lasting response, particularly when used before a liver transplant, by reducing cancer recurrence and improving overall outcomes for patients.
What evidence suggests that this trial's treatments could be effective for liver cancer?
In this trial, participants will receive a combination of durvalumab and tremelimumab before undergoing a liver transplant. Studies have shown that using these drugs together can effectively treat hepatocellular carcinoma (HCC), a common type of liver cancer. Research indicates that this combination has significantly improved overall survival, with some patients living much longer than expected. Specifically, the HIMALAYA study found that this treatment provided a lasting survival benefit over five years. In previous trials, patients with inoperable liver cancer experienced long-term disease control with these drugs. These findings suggest that this combination could help manage liver cancer more effectively.46789
Who Is on the Research Team?
Davendra P. Sohal
Principal Investigator
University of Cincinnati
Are You a Good Fit for This Trial?
This trial is for adults over 18 with hepatocellular carcinoma (HCC) who haven't had prior HCC therapy, are listed for a liver transplant, and meet specific health criteria including a Child-Pugh Score of 5-7. They must have tumors within certain size limits, no extrahepatic disease or severe autoimmune disorders, and be able to follow the study protocol.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive durvalumab and tremelimumab for up to 4 months
Washout
A minimum 28-day washout period before locoregional therapy
Locoregional Therapy
Participants undergo locoregional therapy per institutional standards
Pre-Transplant Washout
A minimum 72-day washout period from the end of immunotherapy before liver transplant
Liver Transplant
Participants undergo liver transplant
Follow-up
Participants are monitored for safety and effectiveness after transplant
Long-term Follow-up
Survival follow-up will continue for 5 years after the end of treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- Liver Transplant
- Tremelimumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
Davendra Sohal
Lead Sponsor