YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV(+) Hepatocellular Carcinoma (HCC) (NCT04000737) | Clinical Trial Compass
CompletedPhase 2
YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV(+) Hepatocellular Carcinoma (HCC)
United States, China62 participantsStarted 2020-01-10
Plain-language summary
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 systemic treatment for patients with Hepatitis B (+) associated advanced hepatocellular carcinoma.
YIV-906 (PHY906, KD018) is an immune system modulator. Clinical and preclinical research suggests that YIV-906 could act to enhance the body's immune response to fight cancer and increase the anti-tumor activity of sorafenib and protect and repair the gastrointestinal tract by reducing inflammation and promoting tissue regeneration.
Inspired by a 1,800-year-old traditional medicine still in use today, YIV-906 is a botanical drug candidate, composed of an extract of four herbs and administered in oral capsule form.
The CALM (Combination of YIV-906 and Sorafenib to treat Advanced Liver cancer in a Multi-center study) trial is a multi-regional, randomized, placebo-controlled study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or females ≥18 years old with ability to take oral drugs
✓. Diagnosis of advanced (locally advanced or metastatic) unresectable/inoperable HCC according to the American Association for the Study of Liver Diseases (AASLD) Guidelines (Heimbach et al. 2018) or diagnosis by tissue pathology
✓. Participants categorized to stage B or C based on Barcelona Clinic Liver Cancer (BCLC) staging system
✓. Life expectancy of at least 3 months
✓. Presence of chronic hepatitis B (HBsAg (+))
✓. Never received systemic antitumor therapy
✓. Patients must have at least one tumor lesion that meets both of the following criteria:
✓. "Measurable disease" according to RECIST1.1, i.e. at least one measurable lesion.
Exclusion criteria
✕. Patients who ever have HCV infection
What they're measuring
1
Progression free survival (PFS)
Timeframe: At baseline, then at the end of every two cycle (i.e. approximately every 8 weeks), until disease progression or discontinuation from study. Assessed up to 24 months.