What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as sorafenib combined with immune system modulators like YIV-906, have known side effects. Sorafenib can cause fatigue, diarrhea, hand-foot skin reactions, hypertension, and increased blood bilirubin levels. Immune system modulators may lead to immune-related adverse effects including colitis, hepatitis, endocrinopathies, and skin reactions. YIV-906, which also protects the gastrointestinal tract, may help reduce some gastrointestinal side effects.

What prior FDA approvals exist?

Sorafenib, a multikinase inhibitor, was one of the first FDA-approved drugs for the treatment of advanced hepatocellular carcinoma (HCC). It works by inhibiting tumor cell proliferation and angiogenesis. More recently, the combination of atezolizumab (an immune checkpoint inhibitor) and bevacizumab (an anti-angiogenic agent) has been approved, showing improved survival rates by enhancing the immune response and targeting tumor blood vessels. These treatments align with the goals of YIV-906, which aims to enhance the immune response, increase the anti-tumor activity of sorafenib, and protect the gastrointestinal tract.

What other types of research exist?

Promising novel alternatives to YIV-906 for liver cancer patients include: 1) Immune checkpoint inhibitors such as anti-PD-1 (e.g., nivolumab) and anti-PD-L1 therapies, which have shown efficacy in enhancing immune response and anti-tumor activity. 2) Combination therapies involving sorafenib with other agents like metronomic tegafur/uracil, which have demonstrated potential in clinical trials. 3) Yttrium-90 radioembolization, which has been effective in treating liver tumors and can be combined with systemic chemotherapy for enhanced outcomes.

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Kinase Inhibitor

YIV-906 + Sorafenib for Liver Cancer

Phase 2

Waitlist Available

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

Never received systemic antitumor therapy

Must not have

Patients who have received systemic chemotherapies or immunotherapy or molecular target therapies or anticancer Chinese medicine Cinobufacini

Patients received any blood transfusion, albumin transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), TPO or other medical supportive treatment within 4 weeks of Cycle 1 treatment

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.

Summary

This trial tests if adding YIV-906 to the standard liver cancer drug sorafenib helps patients with advanced liver cancer linked to Hepatitis B. YIV-906 is a herbal capsule that boosts the immune system and protects the gut, while sorafenib stops cancer cells from growing.

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.

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.

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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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 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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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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I have advanced liver cancer that cannot be removed by surgery.

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I have chronic hepatitis B.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received chemotherapy, immunotherapy, targeted therapy, or Cinobufacini for cancer.

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I haven't received blood products or certain medications in the last 4 weeks.

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I have not had a stroke, mini-stroke, or serious circulation problems in my legs within the last 6 months.

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I am not taking the medication phenytoin (Dilantin).

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I have a bleeding or clotting disorder that is not under control.

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I have not had a heart attack or uncontrolled heart problems in the last 6 months.

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I do not have stomach or bowel problems that affect how I absorb medicine.

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I haven't taken strong CYP3A inducers in the last week.

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I have tested positive for HIV.

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My cancer has spread to my brain or its coverings.

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My cancer is a specific type of liver cancer.

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I am of childbearing age and not using effective birth control.

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I have had bowel obstruction, inflammatory bowel disease, or major gut surgery.

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I haven't had cancer, except for certain skin cancers or cervical pre-cancer, in the last 5 years.

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I have not had any bleeding episodes in the last 4 weeks.

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I have had hepatitis C infection.

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I have a genetic heart condition known as long QT syndrome.

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I had major surgery less than 2 weeks ago or haven't recovered from it.

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I have had an organ transplant.

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I am on a blood thinner like warfarin.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Secondary study objectives

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

0 / 30Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cancer include immune system modulators and tyrosine kinase inhibitors like sorafenib. Immune system modulators, such as YIV-906, enhance the body's immune response to target and destroy cancer cells, increase the anti-tumor activity of drugs like sorafenib, and protect the gastrointestinal tract by reducing inflammation and promoting tissue regeneration. Sorafenib works by inhibiting multiple kinases involved in tumor cell proliferation and angiogenesis. The combination of these treatments is significant for liver cancer patients as it not only targets the cancer cells more effectively but also helps in managing the side effects, improving overall treatment outcomes.