Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)

Sponsor
National Health Research Institutes, Taiwan
Study ID
NCT03510871
Phase
PHASE2
Status
Completed

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab, ipilimumab — DRUG
    All enrolled subjects will receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg intravenously on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles).

Study Details

Objectives: 1. To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC; 2. To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment; 3. To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.

Key Dates

Start date
Feb 12, 2019
Status verified
Jun 2024
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nivolumab plus ipilimumab
    nivolumab plus ipilimumab

Primary Outcome Measure

the percentage of subjects with tumor shrinkage after study drug treatment [ Time Frame: 4 years ]

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