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MTL-CEBPA + Sorafenib for Liver Cancer (OUTREACH2 Trial)
OUTREACH2 Trial Summary
This trial is testing an experimental treatment (MTL-CEBPA) in combination with a standard of care treatment (sorafenib) in patients with advanced liver cancer (hepatocellular carcinoma) as a result of hepatitis B and/or C infection.
OUTREACH2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowOUTREACH2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 87 Patients • NCT02066181OUTREACH2 Trial Design
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- I am fully active or restricted in physically strenuous activity but can do light work.I have not taken any tyrosine kinase inhibitor medications.I have advanced liver cancer with cirrhosis, and a history of hepatitis B or C.I am not a candidate for liver transplantation.I can swallow and keep down pills.I have not had sepsis, issues with bile drainage, jaundice, or brain function problems recently.I am eligible for my first cancer treatment with atezolizumab and bevacizumab.My side effects from previous treatments are mild or gone, except for hair loss or hormone issues which are under control.I haven't had serious heart problems in the last year.I have had an organ transplant.I have not had major surgery in the last 30 days.My liver cancer is of a specific type (fibrolamellar or mixed).I have liver-related brain issues not improved with treatment in the last 6 months.I have HIV with low CD4+ T-cell counts or a history of severe infections.I have not received a live vaccine in the last 30 days.My liver cancer worsened after treatment with atezolizumab and bevacizumab.I am using reliable birth control methods.My cancer has spread to my brain or spinal cord.I have another cancer that has been active or treated in the last 5 years.I have an immune system disorder or I am on long-term steroids.I haven't had significant bleeding episodes in the last 3 months.I am a man and will use effective birth control if my partner can have children.I have never had hepatitis B or C.My liver disease is moderately to severely advanced.I have had bleeding or a tear in my stomach or intestines.I am 18 years old or older.My liver function is good.My liver tumor cannot be surgically removed and hasn't responded to targeted treatments.My liver cancer is at an advanced stage.I have had spontaneous bacterial peritonitis, renal failure, or an allergic reaction recently.My kidneys are functioning well enough to filter waste.I have a significant buildup of fluid in my abdomen.I am not allergic to MTL-CEBPA or sorafenib or their ingredients.
- Group 1: MTL-CEBPA in combination with sorafenib
- Group 2: Sorafenib alone
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are there other investigations utilizing MTL-CEBPA in the literature?
"Presently, 59 clinical trials are in progress researching the effects of MTL-CEBPA. Of these studies, 21 have advanced to Phase 3 with a majority based out of Taibei, Taiwan and 2604 other locations conducting their own investigations."
Is recruitment for this medical trial still open to participants?
"The information displayed on clinicaltrials.gov informs us that this experiment is recruiting participants; the details of which were first published on January 1st 2022 and recently updated February 20th 2022."
What key goals is this clinical trial attempting to achieve?
"To gauge the effectiveness of this trial, investigators will assess anti-tumour activity over a period of approximately one year. Secondary objectives include measuring overall survival, health related quality of life (HRQoL) and evaluating adverse events between both arms using CTCAE v5.0 toxicity criteria."
What is the current enrollment rate for this investigation?
"Indeed, the information accessible on clinicaltrials.gov displays that recruitment for this medical experiment is still underway. The trial was first posted publicly on January 1st 2022 and most recently modified on February 20th 2022. As of now, 150 individuals are being accepted at a single site."
Has the United States Food and Drug Administration sanctioned MTL-CEBPA?
"The safety of MTL-CEBPA, which is in its second phase of testing, was rated a 2. This score implies that there are some observations indicating it can be handled safely but no proof demonstrating effectiveness yet."
In what medical contexts is MTL-CEBPA typically applied?
"MTL-CEBPA is most commonly administered to people suffering from progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc). This pharmaceutical can also be used for managing gastrointestinal stromal tumors, hemangiosarcoma, and leiomyosarcoma."
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