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Durvalumab + Tremelimumab for Liver Cancer (SIERRA Trial)
SIERRA Trial Summary
This trial will test a new cancer treatment to see if it is safe and effective for people with advanced liver cancer.
SIERRA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SIERRA Trial Design
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Who is running the clinical trial?
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- I have had cancer before, but it fits the exceptions.I have a tumor that can be measured and has not been treated with radiation.My liver cancer diagnosis was confirmed through a tissue examination.I have tested positive for HIV or active tuberculosis.I have lasting side effects from cancer treatment that are moderate or worse.I have not had liver-related brain issues or needed medication for it in the last year.My organs and bone marrow are working well.I cannot have surgery for my liver cancer.My liver cancer is at an intermediate or advanced stage.I am receiving treatment for hepatitis B.I have or had an autoimmune or inflammatory disorder.I haven't taken immunosuppressive drugs in the last 14 days.I have had serious heart problems like heart failure, chest pain, or irregular heartbeat.I have hepatitis C confirmed by a positive test result.My liver function and physical ability meet the study's requirements.I am either post-menopausal or using birth control.I do not have any uncontrolled diseases or a history of organ transplant.I have been treated with immune therapies but not cancer vaccines.My partner and I use birth control.I have had cancer spread to the lining of my brain and spinal cord.I have had GI bleeding in the last 6 months.I have both hepatitis B and either hepatitis C or D.My body weight is over 30 kg.I have not had any drug treatments for liver cancer.My liver cancer is a specific type: fibrolamellar, sarcomatoid, or mixed with bile duct cancer.I have significant fluid buildup in my abdomen.I have had, or currently have, cancer spread to my brain or spinal cord.I have ongoing issues with nausea, vomiting, GI disease, swallowing, or had major bowel surgery.
- Group 1: Durvalumab plus Tremelimumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
In how many distinct areas is this experiment being conducted?
"The trial is presently underway at 40 distinct sites, including Shreveport, Bobigny and Clichy. To reduce the necessity of travelling far away for participation in this research effort, please select the closest available location to your current residence."
What potential adverse effects are associated with the combination of Durvalumab and Tremelimumab?
"The combination of Durvalumab and Tremelimumab has a safety rating of 3, due to the presence of data which demonstrates its efficacy as well as multiple instances where it was proven safe in clinical trials."
Are research centers still signing up participants for this trial?
"This particular study, posted on July 14th 2023 and updated May 22nd 2023 is not presently enrolling patients. Nonetheless, there are 2632 other clinical trials actively recruiting participants at the present time."
Does this medical trial offer any eligibility requirements for potential participants?
"This clinical trial is looking for 140 participants with liver cancer aged between 18 to 130."
Does the enrollment criterion for this clinical trial include individuals under 80 years of age?
"To be considered for this medical trial, patients must have a minimum age of 18 years and must not exceed 130. Furthermore, there are 81 clinical trials specifically designed to cater to the needs of those aged under 18 and 2608 studies available for seniors over 65."
What positive results are anticipated from this clinical investigation?
"The primary analysis of this clinical trial will assess the Objective Response Rate (ORR) from first dose to 6 months post-intervention. Secondary endpoints include Overall Survival, Progression Free Survival and Disease Control Rate at Week 16 - all determined with reference to RECIST 1.1 criteria."
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