Nivolumab and Ipilimumab or Nivolumab or Placebo Plus TACE in Intermediate-stage Liver Cancer

JRCT ID: jRCT2031200165

Registered date:20/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma
• Date of first enrollment: 27/11/2020
• Target sample size: 60
• Countries of recruitment: Canada,Japan,United States,Japan,Austria,Japan,Belgium,Japan,Czechia,Japan,France,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Russian Federation,Japan,Spain,Japan,Switzerland,Japan,Brazil,Japan,Argentina,Japan,Australia,Japan,Singapore,Japan,Taiwan,Japan,Korea,Japan,Hong Kong,Japan,China,Japan
• Study type: Interventional

Intervention(s)

Arm A: Nivolumab 240 mg every 2 weeks (Q2W) and ipilimumab 1 mg/kg every 6 weeks (Q6W) plus TACE
Arm B: Nivolumab 240 mg Q2W and ipilimumab placebo Q6W plus TACE
Arm C: Nivolumab placebo Q2W and ipilimumab placebo Q6W plus TACE

Outcome(s)

Primary Outcome

1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C
2. Overall Survival (OS): Arm A versus Arm C

Secondary Outcome

1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C
2. Event-Free Survival (EFS)
3. Progression-free survival (PFS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Marina Tschaika
• Secondary ID(s): NCT04340193