Radiotherapy + Immunotherapy for Liver Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing) after treatment with PD-1 inhibitor immunotherapy. In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive medication, you must stop it at least 14 days before starting the trial, with some exceptions like certain steroids. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Durvalumab and Tremelimumab for liver cancer?
The combination of tremelimumab and durvalumab was approved by the FDA for treating unresectable hepatocellular carcinoma (a type of liver cancer) based on a study showing it improved overall survival compared to another drug, sorafenib. Patients lived a median of 16.4 months with this combination, compared to 13.8 months with sorafenib.12345
Is the combination of durvalumab and tremelimumab safe for humans?
The combination of durvalumab and tremelimumab has been studied for safety in various cancers, including liver cancer. Common side effects include rash, fatigue, diarrhea, itching, muscle pain, and abdominal pain. Serious side effects occurred in about 32.6% of patients, which is higher compared to durvalumab alone.13678
How is the treatment of radiotherapy combined with durvalumab and tremelimumab unique for liver cancer?
This treatment is unique because it combines radiotherapy with two immunotherapy drugs, durvalumab and tremelimumab, which work together to enhance the body's immune response against liver cancer. This combination aims to improve outcomes by using the body's own immune system to fight the cancer, which is different from traditional treatments that may rely solely on surgery or chemotherapy.3591011
Research Team
Mary Feng, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for adults with advanced liver cancer that has worsened after PD-1 inhibitor therapy. They must have manageable hepatitis B, good organ function, no history of certain autoimmune diseases or immunodeficiencies, and not be on conflicting medications or treatments. Participants need to agree to use contraception and have a life expectancy of at least 12 weeks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Patients undergo standard of care hypofractionated radiation therapy over 5 fractions once daily for 5 days
Treatment
Patients receive durvalumab with or without tremelimumab intravenously. Treatment repeats every 28 days for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Durvalumab
- Hypofractionated Radiation Therapy
- 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?
Mary Feng, MD
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology