ivolumab and Ipilimumab or Nivolumab or Placebo Plus TACE in Intermediate-stage Liver Cancer
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- JPRN-jRCT2031200165
- Lead Sponsor
- Marina Tschaika
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
1. Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE
2. Participant has histologic confirmation of HCC
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
4. Men and Women must agree to follow methods of contraception
5. Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC
1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Prior liver transplant or participants who are on the waiting list for liver transplantation
3. Active, known, or suspected autoimmune disease
4. Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
5. Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC
6. Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in association with this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C <br>2. Overall Survival (OS): Arm A versus Arm C
- Secondary Outcome Measures
Name Time Method 1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C<br>2. Event-Free Survival (EFS)<br>3. Progression-free survival (PFS)