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Checkpoint Inhibitor
Immunotherapy for Liver Cancer Before Transplant
Phase 2
Recruiting
Led By Davendra Sohal, MD
Research Sponsored by Davendra Sohal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to randomization
Body weight >30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up survival follow up will continue for 5 years after end of treatment
Awards & highlights
Study Summary
This trial shows that immunotherapy can help people with liver cancer by reducing the amount of cancer before a liver transplant.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests Durvalumab and Tremelimumab in patients with HCC awaiting liver transplants. It aims to see if immunotherapy can safely reduce tumor size and control the disease long-term to improve outcomes post-transplant.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that may affect organs, infusion-related symptoms like fever or chills, fatigue, possible digestive issues such as diarrhea or colitis, skin conditions like rash or itching, hormonal imbalances affecting thyroid function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least one measurable cancer lesion that has not been treated with radiation.
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My body weight is over 30 kg.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My liver tumor fits the specific size and number criteria for transplant.
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I have never received treatment for liver cancer.
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I have liver cancer diagnosed by a biopsy or specific scans.
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I am listed for a liver transplant by the transplant team.
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My liver function score is between 5 and 7.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ survival follow up will continue for 5 years after end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~survival follow up will continue for 5 years after end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cellular rejection rates
Secondary outcome measures
Adverse events during treatment, and graft loss and mortality rates
Pathologic responses via explanted liver assessment
Radiologic responses via RECIST 1.1 and/or mRECIST
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab + Tremelimumab + Liver TransplantExperimental Treatment3 Interventions
Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liver Transplant
2017
N/A
~60
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Find a Location
Who is running the clinical trial?
Davendra SohalLead Sponsor
Davendra Sohal, MDPrincipal InvestigatorUniversity of Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs and bone marrow are working well.I have at least one measurable cancer lesion that has not been treated with radiation.My body weight is over 30 kg.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.I have or had an autoimmune or inflammatory condition, with some exceptions.I have had cancer spread to the lining of my brain and spinal cord.I have not received a live vaccine in the last 30 days.I have had bleeding from varices in the last 3 months.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.I do not have active infections like TB or hepatitis.My cancer has spread outside of the liver.I am 18 years old or older.I am fully active or can carry out light work.I am willing and able to follow the study's treatment plan and attend all visits.My liver tumor fits the specific size and number criteria for transplant.I have never received treatment for liver cancer.I do not have any serious ongoing illnesses that would affect my participation in the study.I have liver cancer diagnosed by a biopsy or specific scans.I am listed for a liver transplant by the transplant team.I had cancer before, but it was treated over 5 years ago and is not likely to come back.I am not pregnant or breastfeeding and willing to use birth control during and up to 6 months after treatment.My liver function score is between 5 and 7.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + Tremelimumab + Liver Transplant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any previous experiments involving Liver Transplantation that have been conducted?
"As of the present time, 340 clinical trials exploring Liver Transplant are currently in progress with 52 studies having entered Phase 3. A majority of these experiments is based out of Cordoba, Texas although 13098 other sites have launched investigations about this topic."
Answered by AI
To what purpose is a Liver Transplant typically employed?
"Liver Transplant is a common treatment for the advanced stage of non-small cell lung cancer that can no longer be surgically removed. It has also been used to address metastatic urothelial carcinoma, as well as facilitate advance directives."
Answered by AI
Is this experiment novel compared to existing studies on the subject?
"Since the 2007 inception of Liver Transplant research, spearheaded by AstraZeneca's sponsored clinical trial involving 37 participants, this intervention has gained Phase 2 drug approval. Presently there are 340 active trials across 58 nations in 1327 cities."
Answered by AI
What is the total participant count in this research project?
"Affirmative. Clinicaltrials.gov verifies that this experiment, which was initially uploaded on December 7th 2021, is seeking participants presently. Approximately 30 individuals must be sourced from 1 distinct healthcare setting."
Answered by AI
Are there still openings for participants in this medical experiment?
"Affirmative. The information available on clinicaltrials.gov reveals that the trial in question, which initially posted on December 7th 2021, is actively recruiting participants. 30 individuals are needed to join 1 medical centre for this study."
Answered by AI
Has the Federal Drug Administration green-lit Liver Transplant?
"While Phase 2 trials don't guarantee clinical efficacy, the safety profile of Liver Transplant was still deemed high enough for a score of 2."
Answered by AI
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