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Clinical trialNCT04000737CompletedPhase 2Interventional

YIV-906 (Formerly PHY906/KD018) With Sorafenib in HBV(+) Hepatocellular Carcinoma (HCC)

SponsorYiviva Inc.Enrollment62Advanced Hepatocellular Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

24 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

China
  • Beijing You'An Hospital, Capital Medical University

    Beijing, Beijing Municipality, China

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, China

  • Foshan Hospital of Traditional Chinese Medicine

    Foshan, Guangdong, China

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong, China

  • the First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, China

  • Shenzhen People'S Hospital

    Shenzhen, Guangdong, China

  • the First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • Hunan Cancer Hospital

    Changsha, Hunan, China

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, China

  • Shanghai Eastern Hepatobiliary Hospital

    Shanghai, Shanghai Municipality, China

  • Shanghai University of Traditional Chinese Medicine Shuguang Hospital

    Shanghai, Shanghai Municipality, China

Hong Kong
  • Queen Mary Hospital

    Hong Kong, Hong Kong

Taiwan
  • China Medical University Hospital

    Taichung, Taiwan

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • Cancer Research Center, Taipei Municipal Wanfang Hospital

    Taipei, Taiwan

  • Taipei Medical University -Shuang Ho Hospital, Ministry of Health and Welfare

    Taipei, Taiwan

  • Taipei Medical University Cancer Center

    Taipei, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Taiwan

United States
  • Calvin Pan. Md Gastroenterology & Hepatology Clinic

    Flushing, New York, United States

  • Northwell Monter Cancer Institute

    Lake Success, New York, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Sorafenib+YIV-906Sorafenib+placebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
10 Jan 2020
Primary completion
22 Mar 2024
Completion
19 Nov 2024
Last update posted
13 Apr 2025
Registered enrollment
62
Registry id
NCT04000737
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.