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Kinase Inhibitor

YIV-906 + Sorafenib for Liver Cancer

Phase 2
Recruiting
Research Sponsored by Yiviva Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40mL/min (using the Cockcroft-Gault equation: (140-age) x weight (kg)/ (serum creatinine x 72 [mg/dL] for males. (For females multiply by 0.85) AND
Adequate renal function, based upon meeting the following laboratory criteria within 7 days before randomization:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. assessed up to 24 months.
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 with advanced liver cancer linked to Hepatitis B, who can take oral medication and have not had prior systemic antitumor therapy. They should be in a specific stage of liver cancer (BCLC stage B or C), have good organ function, no severe medical conditions, and must use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests the combination of YIV-906 (an herbal immune system modulator) with sorafenib against sorafenib alone in treating advanced hepatocellular carcinoma. It's a randomized, placebo-controlled trial where participants are assigned by chance to either receive the experimental treatment or a placebo alongside standard care.See study design
What are the potential side effects?
Potential side effects include those commonly associated with immunomodulators such as changes in immune system activity which could lead to inflammation or infection risks. Sorafenib-related side effects may include skin reactions, diarrhea, high blood pressure, and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the required range.
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My kidney function is good based on recent tests.
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I am 18 or older and can take pills.
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I am 18 or older and can take pills.
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I have never had treatment that affects my whole body for cancer.
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My liver disease is mild according to the Child-Pugh class A.
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I am fully active or can carry out light work.
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My liver cancer cannot be surgically removed and has not responded to local treatments, or it has spread beyond my liver.
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My liver cancer is at stage B or C according to the BCLC system.
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I am receiving treatment for hepatitis B and started it 1-2 weeks before the study drug.
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My organs are functioning well according to my recent lab tests.
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My liver cancer cannot be removed by surgery.
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I have a tumor that can be measured.
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My liver cancer cannot be surgically removed and has not responded to local treatments, or it has spread beyond my liver.
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My liver cancer is at stage B or C according to the BCLC system.
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I have advanced liver cancer that cannot be removed by surgery.
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I have chronic hepatitis B.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. assessed up to 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and at randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Change of quality of life (QoL) in each arm with EORTC-C30
Change of quality of life (QoL) in each arm with HCC18
Disease control rate (DCR) in each arm
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sorafenib + YIV-906Experimental Treatment1 Intervention
Patients in the study arm will be treated orally for 28-day courses with YIV-906 + sorafenib
Group II: Sorafenib + PlaceboActive Control1 Intervention
Patients in the placebo arm will be given sorafenib with placebo

Find a Location

Who is running the clinical trial?

Yiviva Inc.Lead Sponsor
Ghassan Abou-Alfa, MD/MBAStudy ChairMemorial Sloan Kettering Cancer Center
Yun Yen, MD/PhDStudy ChairTaipei Medical University

Media Library

Sorafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04000737 — Phase 2
Liver Cancer Research Study Groups: Sorafenib + YIV-906, Sorafenib + Placebo
Liver Cancer Clinical Trial 2023: Sorafenib Highlights & Side Effects. Trial Name: NCT04000737 — Phase 2
Sorafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04000737 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~24 spots leftby Mar 2025