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Compensation: Varies

Number of Visits: 4

Duration: 24 months

62 Participants Needed

YIV-906 + Sorafenib for Liver Cancer

Recruiting at 26 trial locations

Overseen ByShwu-huey Liu, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yiviva Inc.

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

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Sorafenib in treating liver cancer?

Sorafenib has been shown to improve survival in patients with advanced liver cancer, as demonstrated in the SHARP and Sorafenib Asia-Pacific trials, which found that patients taking Sorafenib lived longer than those who did not. It is currently the only approved drug for systemic treatment of liver cancer and is recommended for patients with advanced stages of the disease.¹ ² ³ ⁴ ⁵

Is the combination of YIV-906 and Sorafenib safe for liver cancer treatment?

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. While specific safety data for the combination with YIV-906 is not provided, Sorafenib alone has a well-characterized safety profile.¹ ³ ⁵ ⁶ ⁷

How does the drug YIV-906 + Sorafenib differ from other liver cancer treatments?

The combination of YIV-906 and Sorafenib is unique because Sorafenib is an oral drug that targets multiple pathways involved in cancer growth, such as the VEGF pathway, while YIV-906 is a traditional Chinese medicine that may enhance the effects of Sorafenib and help manage side effects, offering a novel approach compared to standard treatments.¹ ³ ⁴ ⁸ ⁹

Research Team

Yun Yen, MD/PhD

Principal Investigator

Taipei Medical University

Ghassan Abou-Alfa, MD/MBA

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

See 19 more

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.

See 29 more

Timeline

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

Treatment Details

Interventions

Sorafenib
YIV-906

Trial OverviewThe 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.

Participant Groups

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

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yiviva Inc.

Lead Sponsor

Trials

Recruited

130+

Findings from Research

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]