YIV-906 + Sorafenib for Liver Cancer

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yiviva Inc.

No Placebo Group

Prior Safety Data

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.

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.

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Calvin Pan. MD Gastroenterology & Hepatology Clinic Flushing, NY

Memorial Sloan Kettering Cancer Center New York, NY

Who Is Running the Clinical Trial?

Yiviva Inc. Lead Sponsor

References