YIV-906 + Sorafenib for Liver Cancer

No longer recruiting at 29 trial locations

Overseen By Shwu-huey Liu, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yiviva Inc.

Must be taking: Anti-HBV treatment

Must not be taking: Corticosteroids, Anticoagulants, NSAIDs, others

Disqualifiers: HCV infection, HIV, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding YIV-906, an immune-boosting herbal capsule, to the standard liver cancer treatment sorafenib (Nexavar) is more effective than using sorafenib alone. Inspired by ancient traditional medicine, YIV-906 may help the body fight cancer and reduce inflammation. The trial targets individuals with advanced liver cancer linked to Hepatitis B who have not yet received systemic treatment. Participants should have a measurable liver tumor and chronic Hepatitis B. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but you cannot take certain medications like phenytoin, strong inducers of CYP3A, or traditional Chinese medicines within 14 days before starting the trial. You must also be on anti-HBV treatment if you have positive HBV-DNA and HBsAg.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that patients generally tolerate the combination of YIV-906 and sorafenib well. Studies indicate that this combination yields better results and is more comfortable for patients compared to sorafenib alone. Sorafenib, a common liver cancer treatment, can cause side effects like skin reactions, but these are manageable.

Inspired by traditional medicine, YIV-906 may strengthen the immune system and reduce inflammation, potentially enhancing the body's ability to fight cancer and protect the digestive system. While side effects exist, evidence so far suggests that adding YIV-906 to sorafenib does not increase overall risk and might even improve patient tolerance. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for liver cancer?

Researchers are excited about the combination of YIV-906 and sorafenib for liver cancer because YIV-906 introduces a novel approach by incorporating traditional herbal medicine with modern cancer treatment. Unlike standard treatments that typically focus solely on targeting cancer cells, YIV-906 may enhance the body's immune response and improve the effectiveness of sorafenib, a standard liver cancer drug. This combination not only has the potential to boost the efficacy of existing treatments but also to reduce side effects, making it a promising option for patients seeking more comprehensive cancer care.

What evidence suggests that YIV-906 plus sorafenib could be an effective treatment for liver cancer?

This trial will compare the combination of YIV-906 with sorafenib to sorafenib with a placebo. Research has shown that combining YIV-906 with sorafenib enhances the body's immune response against liver cancer. Studies have found that this combination improves treatment efficacy and is easier for patients to tolerate than sorafenib alone. In earlier trials, patients demonstrated better anti-tumor results and experienced fewer side effects. YIV-906 also protects the digestive system by reducing inflammation and aiding healing. These findings suggest that this combination could be a promising treatment for advanced liver cancer linked to Hepatitis B. ^{1 2 3 4 5}

Who Is on the Research Team?

Yun Yen, MD/PhD

Principal Investigator

Taipei Medical University

Ghassan Abou-Alfa, MD/MBA

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My kidney function is within the required range.

Ability to understand and willingness to sign a written informed consent and to be able to follow the visit schedule

My kidney function is good based on recent tests.

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive YIV-906 plus sorafenib or placebo plus sorafenib in 28-day cycles

24 months

Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Optional continuation of treatment for participants showing benefit

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Sorafenib
• YIV-906

Trial Overview 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.

How Is the Trial Designed?

Group I: Sorafenib + YIV-906 Experimental Treatment 1 Intervention

Patients in the study arm will be treated orally for 28-day courses with YIV-906 + sorafenib

Group II: Sorafenib + Placebo Active Control 1 Intervention

Patients in the placebo arm will be given sorafenib with placebo

Sorafenib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Nexavar for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in United States as Nexavar for:

• Renal cell carcinoma
• Hepatocellular carcinoma
• Radioactive iodine-refractory differentiated thyroid carcinoma

Approved in Canada as Nexavar for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Japan as Nexavar for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Who Is Running the Clinical Trial?

Yiviva Inc.

Lead Sponsor

Trials

1

Recruited

130+

Published Research Related to This Trial

Sorafenib is an oral kinase inhibitor that effectively targets multiple tyrosine kinases involved in cancer, including pathways like raf-ras and VEGF, which are often disrupted in tumors.

The FDA has approved sorafenib for advanced renal cell cancer and hepatocellular cancer, and it has shown promising clinical activity in thyroid cancer, with ongoing trials exploring its use in combination therapies for various cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sorafenib. Hasskarl, J.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04000737

YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV ... The aim of this study is to compare the efficacy and safety of YIV-906 plus standard-of-care sorafenib versus those of sorafenib alone as a first-line ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7930412/

A Phase II Clinical Trial on the Combination Therapy ... Our data showed that PHY906 increases the therapeutic index of capecitabine by enhancing its antitumor activity and reduces its toxicity profile in advanced HCC ...

3. withpower.com withpower.com/trial/phase-3-carcinoma-hepatocellular-2020-6eb9b

YIV-906 + Sorafenib for Liver Cancer · Info for Participants Sorafenib, also known as Nexavar, has been used safely in treating liver cancer, with known side effects like hand-foot skin reactions that can be managed.

4. firstwordpharma.com firstwordpharma.com/story/5979233

Yiviva Presents Phase 2b Results for YIV-906 in ... The study demonstrated improvements in both efficacy and tolerability for patients treated with YIV-906 plus sorafenib versus sorafenib monotherapy.

5. synapse.patsnap.com synapse.patsnap.com/drug/cdf4fc3455f74e81b9ec3ea5d91bd614

YIV-906 - Drug Targets, Indications, Patents Yiviva Presents Phase 2b Results for YIV-906 in Combination with Sorafenib in Advanced Hepatocellular Carcinoma at ASCO and ESMO GI 2025. July 07, 2025 -- ...