Pembrolizumab as Neoadjuvant Treatment in HCC

• Status: Unknown status
• Trial end date: 2020-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kindai University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.