Clinical Trials List
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
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Yiviva Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 劉奕廷 NA
- Yih-Jyh Lin NA
- 顏志傑 NA
- Chiu Hung Chiu NA
- 簡世杰 NA
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 夏和雄 NA
- Cheng-I Hsieh NA
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Yao Chen NA
- Wei-Hong Cheng NA
- HUI-WEN LIU NA
- 李宗穎 Digestive System Department
- Ming-Zhe Tay Digestive System Department
- Yao-Yu Hsieh NA
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- I-Cheng Lee NA
- Pei-Chang Lee NA
- Chien-An Liu NA
- Yi-Hsiang Huang NA
- Chung-Pin Li NA
- Yi-Ping Hung NA
- 姜乃榕 NA
- Ming-Huang Chen NA
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 吳宗翰 NA
- Wei-Chen Lee NA
- Kun-Ming Chan NA
- 呂嘉偉 NA
- Shi-Ming Lin NA
- 王瑜肇 NA
- 李兆偉 NA
- Jen-Shi Chen NA
- 吳庭榕 NA
- 周宏學 NA
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Cheng-Yuan Peng Digestive System Department
- Hung-Wei Wang NA
- Hsueh-Chou Lai Digestive System Department
- 許士超 Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
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
Exclusion Criteria
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
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Taiwan
25 participants
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Global
125 participants
