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Checkpoint Inhibitor
SIRT + Immunotherapy for Liver Cancer
Phase 1
Recruiting
Research Sponsored by Jiping Wang, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will evaluate the safety & effectiveness of immunotherapies & radiation for people with resectable HCC who will undergo liver surgery.
Who is the study for?
Adults with resectable hepatocellular carcinoma (HCC) who haven't been treated for it before can join this trial. They should have a certain level of liver function, no history of other cancers affecting the study, and be able to understand and sign consent. Women must test negative for pregnancy and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the safety of combining two immunotherapies, Tremelimumab and Durvalumab, with or without SIRT (a type of targeted radiation therapy), in patients planning to undergo liver surgery for HCC.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect various organs, infusion reactions from the drugs being administered, fatigue, potential digestive issues like diarrhea or colitis, as well as an increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events
Secondary outcome measures
Best Pathological Response
Best Radiologic Response
CD8+/CD4+T Cells Level
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Durvalumab + Tremelimumab + SIRT (Arm B)Experimental Treatment3 Interventions
-Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined:
Neoadjuvant Treatment:
Cycle 1:
Day 3 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab
Day 31 of 28 Day Cycle: Pre-determined dose of Durvalumab
Day 1 of 28 Day Cycle: Yttrium-90
Participants will undergo surgery on Day 52 of Cycle 1. Surgery will be performed per institutional standard of care.
Adjuvant Treatment:
--Cycles 1 (28 days postoperatively) - 13:
---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab
Group II: Durvalumab + Tremelimumab (Arm A)Experimental Treatment2 Interventions
-Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined:
Neoadjuvant Treatment:
Cycle 1:
Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab
Day 28 of 28 Day cycle: Pre-determined dose of Durvalumab
Participants will undergo surgery on day 49 of Cycle 1. Surgery will be performed per institutional standard of care.
Adjuvant Treatment:
--Cycles 1 (28 days postoperatively) - 13:
---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SIRT
2010
Completed Phase 4
~60
Tremelimumab
2017
Completed Phase 2
~3380
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Jiping Wang, MD, PhDLead Sponsor
AstraZenecaIndustry Sponsor
4,272 Previous Clinical Trials
288,612,655 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Sirtex MedicalIndustry Sponsor
28 Previous Clinical Trials
4,250 Total Patients Enrolled
1 Trials studying Liver Cancer
36 Patients Enrolled for Liver Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need nutrition through an IV including fats.I haven't had major surgery or a significant injury in the last 6 weeks.I am fully active and can carry on all pre-disease activities without restriction.My body weight is over 30 kg.I am capable of becoming pregnant and have a negative pregnancy test.I have serious wounds, ulcers, fractures, or lung diseases.My organs and bone marrow are functioning well.I haven't taken immunosuppressive drugs in the last 14 days, with some exceptions.I do not have any unmanaged ongoing illnesses.I have a history of blood clotting or bleeding disorders.I have not had any serious illnesses recently.I have or had an autoimmune or inflammatory disorder, with some exceptions.I have another cancer that won't affect this treatment's safety or results.I am 18 years old or older.I have received treatment for liver cancer before.My liver cancer diagnosis was confirmed through a biopsy or clinical criteria.I have a brain tumor, brain metastases, or a specific neurological condition.I have not received any treatment for liver cancer.I agree to use birth control methods if I can have children.My disease can be surgically removed and my liver is functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab + Tremelimumab + SIRT (Arm B)
- Group 2: Durvalumab + Tremelimumab (Arm A)
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.
Has the combination of Durvalumab and Tremelimumab (Arm A) achieved regulatory approval?
"The safety of the Durvalumab + Tremelimumab (Arm A) combination was rated as a 1 on our scale, due to its Phase 1 trial status. This indicates that there is minimal evidence supporting both efficacy and safety."
Answered by AI
Does this clinical trial offer the opportunity for enrollment at present?
"As per the clinicaltrials.gov database, this study is no longer actively seeking participants having first been posted on May 1st 2023 and last updated on January 18th 2023. Although not currently recruiting patients, there are presently 2686 other trials that require enrollees."
Answered by AI
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