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Clinical Trials List

Protocol NumberYIV-906-2018L1
Completed

2019-08-01 - 2025-06-30

Phase II

Terminated7

ICD-10C22.0

Liver cell carcinoma

ICD-10C22.2

Hepatoblastoma

ICD-10C22.3

Angiosarcoma of liver

ICD-10C22.4

Other sarcomas of liver

ICD-10C22.7

Other specified carcinomas of liver

ICD-10C22.8

Malignant neoplasm of liver, primary, unspecified as to type

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9155.0

Malignant neoplasm of liver, primary

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Yiviva Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Jui Yen NA

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wei-Yu Kao Digestive System Department

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator TSU-YI CHAO NA

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

The Actual Total Number of Participants Enrolled

0 Terminated

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Long-Bin Jeng Division of Others -

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Advanced Hepatocellular Carcinoma

Objectives

To determine the progression free survival (PFS) in each arm

Test Drug

tablets

Active Ingredient

YIV-906

Dosage Form

130

Dosage

200mg

Endpoints

ary endpoints
To determine the effect of YIV-906 on progression-free survival (PFS). PFS measured as time
from randomization to progression or death due to any cause, whichever occurs first. Log-rank test will be
used to determine the effect of YIV-906 on PFS. The RECIST 1.1 will be used to establish disease response
or progression at the study sites. In addition, an independent radiologist will blindly perform tumor
assessments using both RECIST 1.1 and the mRECIST.

Inclution Criteria

1. Male or females ≥18 years old with ability to take oral drugs

Exclusion Criteria

1. Patients who ever have HCV infection
2. Patients who have received systemic chemotherapies or immunotherapy or
molecular target therapies or anticancer Chinese medicine Cinobufacini
3. Patients who have received any local anti-cancer therapy within 4 weeks prior
to Cycle 1 treatment
4. Active bleeding (including gastrointestinal bleeding) during the last 4 weeks
prior to Cycle 1 treatment
5. Patients with a history of allergy to the known components of YIV-906
6. Known history of human immunodeficiency virus (HIV) seropositivity
7. Known central nervous system metastasis including brain metastasis and
meningeal carcinomatosis
8. Hepatocholangiocarcinoma, fibrolamellar cell carcinoma and mixed
hepatocellular carcinoma
9. Active malignancy (except for definitively treated melanoma in-situ, basal or
squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within
the past 5 years

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    125 participants