Pembrolizumab as Neoadjuvant Treatment in HCC

NCT ID: NCT03337841

Last Updated: 2017-11-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2020-10-31

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 administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.) Subjects who discontinue for reasons other than tumor recurrence will have post-treatment follow-up visits for monitoring disease status until tumor recurrence, until initiation of non-study cancer treatment, until withdrawal of consent for study participation, or until becoming lost to follow-up. All subjects will be followed for overall survival until death, withdrawal of consent for study participation, or the end of the study, whichever comes first. After the end of trial treatment, each subject will be followed for 30 days for adverse event monitoring. Serious adverse events will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy, whichever is earlier.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Neo adjuvant chemotherapy; Adjuvant chemotherapy; Immune checkpoint inhibitor; Pembrolizumab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pembrolizumab

Pembrolizumab 200 mg IV once only in the neoadjuvant phase. Pembrolizumab 200 mg IV every 3 weeks in the adjuvant phase.

Group Type: EXPERIMENTAL

Pembrolizumab

Intervention Type: DRUG

Each subject will receive administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.)

Interventions

Pembrolizumab

Each subject will receive administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.)

Intervention Type: DRUG

Other Intervention Names

MK-3475; Keytruda

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Kindai University

OTHER

Sponsor Role: lead

Responsible Party

Masatoshi Kudo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masatoshi Kudo, Professor

Role: PRINCIPAL_INVESTIGATOR

Kindai University Faculty of Medicine, Gastroenterology and Hepatology

Central Contacts

Kazuomi Ueshima, Lecturer

Role: CONTACT

Phone: +81-72-366-0221

Email: kaz-ues@med.kindai.ac.jp

Masatoshi Kudo, Professor

Role: CONTACT

Phone: +81-72-366-0221

Email: m-kudo@med.kindai.ac.jp

Other Identifiers

AURORA study

Identifier Type: -

Identifier Source: org_study_id