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YIV-906 + Sorafenib for Liver Cancer
Study Summary
This trial is testing if YIV-906, an extract of four herbs, can help fight Hepatitis B associated advanced liver cancer when used with the standard-of-care treatment, sorafenib.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My kidney function is within the required range.You are expected to live for at least three more months.I have received chemotherapy, immunotherapy, targeted therapy, or Cinobufacini for cancer.I am on chronic NSAIDs or anti-platelet agents, but I take aspirin at doses up to 100mg/day.I have not taken any traditional Chinese medicines in the last 14 days.I haven't received blood products or certain medications in the last 4 weeks.My kidney function is good based on recent tests.I have not had a stroke, mini-stroke, or serious circulation problems in my legs within the last 6 months.I am 18 or older and can take pills.I am 18 or older and can take pills.I am not taking the medication phenytoin (Dilantin).I have a bleeding or clotting disorder that is not under control.I have not had a heart attack or uncontrolled heart problems in the last 6 months.I do not have stomach or bowel problems that affect how I absorb medicine.I haven't taken strong CYP3A inducers in the last week.I am on long-term steroids or immunosuppressants, but not more than 10 mg/day of prednisone.I do not have any uncontrolled infections or illnesses that could worsen with this study's treatment, except for chronic HBV.You currently have or recently had a problem with your immune system, mental health, or drug abuse that is not under control.I do not have any severe or uncontrolled medical conditions.My liver disease is mild according to the Child-Pugh class A.I have tested positive for HIV.My cancer has spread to my brain or its coverings.I am fully active or can carry out light work.My liver cancer cannot be surgically removed and has not responded to local treatments, or it has spread beyond my liver.My cancer is a specific type of liver cancer.My liver cancer is at stage B or C according to the BCLC system.I am receiving treatment for hepatitis B and started it 1-2 weeks before the study drug.My organs are functioning well according to my recent lab tests.I had major surgery less than 2 weeks ago or haven't recovered from it.I have never had treatment that affects my whole body for cancer.I am of childbearing age and not using effective birth control.I have had bowel obstruction, inflammatory bowel disease, or major gut surgery.You are expected to live for at least 3 more months.I haven't had cancer, except for certain skin cancers or cervical pre-cancer, in the last 5 years.My liver cancer cannot be removed by surgery.I have not had any bleeding episodes in the last 4 weeks.You have had an allergic reaction to the ingredients in YIV-906 before.I haven't had any local cancer treatments in the last 4 weeks.You are someone who drinks alcohol regularly.I have had hepatitis C infection.I have a genetic heart condition known as long QT syndrome.I have a tumor that can be measured.I have had an organ transplant.My liver cancer cannot be surgically removed and has not responded to local treatments, or it has spread beyond my liver.My liver cancer is at stage B or C according to the BCLC system.I have advanced liver cancer that cannot be removed by surgery.I have chronic hepatitis B.I am on a blood thinner like warfarin.
- Group 1: Sorafenib + YIV-906
- Group 2: Sorafenib + Placebo
- 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
What other drugs have been studied alongside YIV-906+Sorafenib?
"Currently, there are 65 ongoing clinical trials studying the efficacy of YIV-906+Sorafenib. Out of those, 24 have reached Phase 3 testing. Most of these studies taking place in Taibei, Taiwan; though there are 2804 research sites for this medication globally."
Are recruitment efforts for this research still ongoing?
"The date on clinicaltrials.gov suggests that this study is still looking for patients to enroll. This trial was first announced on January 10th 2020 with the most recent update being from July 11th 2022."
What is YIV-906+Sorafenib generally prescribed for?
"YIV-906+Sorafenib is an effective treatment for progressive, metastatic radioactive iodine-refractory differentiated thyroid carcinoma (dtc) as well as other conditions such as gastrointestinal stromal tumors, leiomyosarcoma, and hemangiosarcoma."
Is it dangerous to take YIV-906+Sorafenib?
"There is limited data to support the safety of YIV-906+Sorafenib, as this medication is still in Phase 2 clinical trials."
With how many individuals is this experiment being conducted?
"That is correct. According to the latest information on clinicaltrials.gov, this trial is still recruiting patients. This particular study was first posted on 1/10/2020, and the website was updated as recently as 7/11/2022. The research team is looking for 125 people total, but they need to be at one of the two locations."
Who else is applying?
How old are they?
What portion of applicants met pre-screening criteria?
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