A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Trial ID or NCT#
NCT03383458
Status
NOT RECRUITING
Purpose
This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
Official Title
A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Participants with a first diagnosis of HCC who have undergone a curative resection or ablation - Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC - Child-Pugh Score 5 or 6 - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria:
- - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - Any evidence of tumor metastasis or co-existing malignant disease - Participants previously receiving any prior therapy for HCC, including loco-regional therapies - Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation - Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella [MMR]). Other protocol defined inclusion/exclusion criteria apply
Investigator(s)
Gregory M. Heestand, MD
Medical oncologist,
Gastrointestinal specialist
Clinical Associate Professor, Medicine - Oncology
Contact us to find out if this trial is right for you.
Contact
Flordeliza Mendoza
650-724-2056
View on ClinicalTrials.gov
