Pembrolizumab as Neoadjuvant Treatment in HCC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03337841|
Recruitment Status : Unknown
Verified November 2017 by Masatoshi Kudo, Kindai University.
Recruitment status was: Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma With Pembrolizumab Trial (AURORA)|
|Estimated Study Start Date :||November 10, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2020|
Pembrolizumab 200 mg IV once only in the neoadjuvant phase. Pembrolizumab 200 mg IV every 3 weeks in the adjuvant phase.
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.)
- One-year recurrence-free survival rate [ Time Frame: 1 year after curative treatment ]One-year recurrence-free survival rate is defined as the recurrence-free survival rate 1year after curative treatment.
- Recurrence free survival [ Time Frame: 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. ]Recurrence-free survival is defined as the length of time from the date of confirmation of complete cure to the earliest of the following: the date when recurrence is diagnosed or the date of death due to any cause.
- Overall survival [ Time Frame: From date of enrollment until the date of death from any cause, up to 72 weeks. ]Overall survival is defined as the length of time from the date of confirmation of complete cure to the date of death due to any cause.
- Objective response rate after neoadjuvant phase [ Time Frame: Evaluation period is just before curative treatment, up to 4 weeks. ]Tumor assessment in accordance with RECIST1.1 will be performed after neoadjuvant administration.
- Tumor markers [ Time Frame: From the date of enrollment until the date of last administration of study drug, up to 72 weeks. ]Baseline levels of tumor markers including AFP, AFP-L3, and PIVKA-II and changes in their levels will be exploratory investigated in relation to the therapy efficacy.
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From the date of enrollment until the date of last administration of study drug, thereafter up to 4 months ]The safety endpoints of this study are the safety of pembrolizumab as neoadjuvant and/or adjuvant therapy in patients with HCC. To determine the safety of the drug, the degree of toxicity is evaluated in accordance with the CTCAE (version 4.0).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337841
|Contact: Kazuomi Ueshima, Lecturer||+81-72-366-0221 ext email@example.com|
|Contact: Masatoshi Kudo, Professor||+81-72-366-0221 ext firstname.lastname@example.org|
|Principal Investigator:||Masatoshi Kudo, Professor||Kindai University Faculty of Medicine, Gastroenterology and Hepatology|