Pembrolizumab as Neoadjuvant Treatment in HCC

NCT03337841 | Unknown Phase 2 DMC

• 1 other identifier: AURORA study
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• One-year recurrence-free survival rate

  One-year recurrence-free survival rate is defined as the recurrence-free survival rate 1year after curative treatment.

  1 year after curative treatment

Secondary Outcomes (5)

• Recurrence free survival

  From the date of enrollment until the date of first recurrence or date of death from any cause, whichever came first, up to 72 weeks.

• Overall survival

  From date of enrollment until the date of death from any cause, up to 72 weeks.

• Objective response rate after neoadjuvant phase

  Evaluation period is just before curative treatment, up to 4 weeks.

• Tumor markers

  From the date of enrollment until the date of last administration of study drug, up to 72 weeks.

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From the date of enrollment until the date of last administration of study drug, thereafter up to 4 months

Study Arms (1)

Pembrolizumab

EXPERIMENTAL

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

Drug: Pembrolizumab

Interventions

Pembrolizumab 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.)

Also known as: MK-3475, Keytruda

Pembrolizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kindai University: lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Masatoshi Kudo, Professor

  Kindai University Faculty of Medicine, Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kazuomi Ueshima, Lecturer

CONTACT

+81-72-366-0221; kaz-ues@med.kindai.ac.jp

Masatoshi Kudo, Professor

CONTACT

+81-72-366-0221; m-kudo@med.kindai.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 9, 2017
• Study Start: November 10, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2020
• Last Updated: November 9, 2017

Record last verified: 2017-11