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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.

Study Details

Age(s): 18 Years and older

Condition or Disease: Advanced Hepatocellular Carcinoma

Intervention/Treatment: Drug: YIV-906+Sorafenib, Drug: Placebo+Sorafenib

Phase: Phase 2

Study Type: Interventional

Estimated Enrollment: 125

Primary Purpose: Treatment

Actual Study Start Date: January 10, 2020

Estimated Primary Completion Date: December 31, 2021

Estimated Study Completion Date: February 28, 2022 12:00 am

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General Information

Yiviva Inc.

Trial Name:
A Phase II Randomized Placebo-Controlled Study Investigating The Combination Of YIV-906 And Sorafenib (Nexavar®) In HBV (+) Patients With Advanced Hepatocellular Carcinoma

Trial Number:
YIV-906-2018L1 Identifier:

Recruitment Status:

First Posted:
June 27, 2019

Last Update Posted:
July 7, 2019