Status:
UNKNOWN
Pembrolizumab as Neoadjuvant Treatment in HCC
Lead Sponsor:
Kindai University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to elucidate the utility of the immune checkpoint inhibitor pembrolizumab in preventing the recurrence of HCC when administered before and after curative surgery or ablation.
Detailed Description
Each subject will participate in the trial from the time he or she signs the informed consent form until the final contact. After a screening phase of up to 28 days, each subject will receive administ...
Eligibility Criteria
Inclusion
- Hepatocellular carcinoma for which radical cure is possible by resection or RFA.
- Diagnosed with typical HCC based on imaging findings with Intermediate or High Risk of recurrence as assessed by tumor characteristics.
- Male or female subjects \>/= 20 years of age
- Child-Pugh score A
- ECOG Performance Status of 0.
- Adequate bone marrow, liver and renal function
Exclusion
- Recurrent HCC
- HCC with extrahepatic metastasis and/or vascular invasion confirmed by diagnostic imaging
- Subjects with poorly controlled ascites (excluding cases that responded to diuretic therapy)
- Subjects with hepatic encephalopathy
- Past history of immunotherapy
- Past history or complication of an active autoimmune disorder.
- Past history or complication of interstitial pneumonia.
- Past or current history of malignant tumor, except for curative cases
- Subjects with renal insufficiency requiring hemodialysis or peritoneal dialysis.
- Past or current history of severe cardiovascular disease
- Active clinically serious infections except for HBV or HCV
- Subjects with convulsive disorder requiring treatment (risk of convulsive seizures).
- Subjects with gastrointestinal bleeding causing clinical problems within a 4-week period before enrollment in this study.
- Subjects with thrombosis or embolism that developed within a 6-month period before enrollment in this study
- Subjects with pregnant or breast feeding, or planning to become a parent
- Subjects with possible allergic reaction to the investigational drug.
Key Trial Info
Start Date :
November 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03337841
Start Date
November 10 2017
End Date
October 31 2020
Last Update
November 9 2017
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