Clinical Trials List
2020-06-30 - 2023-12-12
Phase III
Recruiting2
Terminated7
ICD-9V10.07
Personal history of malignant neoplasm of liver
A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- PEI-JER CHEN 無
- 蘇東弘 無
- Jia-Horng Kao 無
- - - 無
- Shih-Jer Hsu 無
- Chia-Chi Lin 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hsin-Yu Kuo 無
- Liu Yi-Sheng 無
- 邱彥程 無
- Chiu Hung Chiu 無
- Yih-Jyh Lin 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Yi-Chung Hsieh 無
- 呂嘉偉 無
- Wei-Chen Lee 無
- 吳庭榕 無
- 鄭志軒 無
- 周宏學 無
- 吳宗翰 無
- 王瑜肇 無
- Kun-Ming Chan 無
- Chia-Hsun Hsieh 無
- 陳奎安 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Zu-Yau Lin 無
- 黃駿逸 無
- Jee-Fu Huang 無
- Wan-Long Chuang 無
- Chung-Feng Huang 無
- Chia-Yen Dai 無
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
nivolumab
Dosage Form
Injection
Dosage
10mg/mL
Endpoints
Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C [ Time Frame: up to 2 years ]
Overall Survival (OS): Arm A versus Arm C [ Time Frame: up to 2.5 years ]
Secondary Outcome Measures :
Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C [ Time Frame: up to 2 years ]
Overall Survival (OS): Arm B versus Arm C [ Time Frame: up to 2.5 years ]
Event-Free Survival (EFS) [ Time Frame: up to 2 years ]
Progression-free survival (PFS) [ Time Frame: up to 2 years ]
Inclution Criteria
Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE
Participant has histologic confirmation of HCC
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Men and Women must agree to follow methods of contraception
Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC
Exclusion Criteria
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Prior liver transplant or participants who are on the waiting list for liver transplantation
Active, known, or suspected autoimmune disease
Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC
Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in association with this trial
The Estimated Number of Participants
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Taiwan
15 participants
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Global
765 participants
