Hepatocellular CarcinomaPhase 2NCT03337841
Pembrolizumab as Neoadjuvant Treatment in HCC
A Phase 2 study testing Pembrolizumab in people with Hepatocellular Carcinoma, run by Kindai University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2017to 31 Oct 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neoadjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma With Pembrolizumab Trial (AURORA)
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.
Read the 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
- Being tested
- Pembrolizumab
- Keywords
- Hepatocellular carcinoma, Neo adjuvant chemotherapy, Adjuvant chemotherapy, Immune checkpoint inhibitor, Pembrolizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475, Keytruda
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.)
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | Pembrolizumab 200 mg IV once only in the neoadjuvant phase. Pembrolizumab 200 mg IV every 3 weeks in the adjuvant phase. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year recurrence-free survival rate
One-year recurrence-free survival rate is defined as the recurrence-free survival rate 1year after curative treatment.
Measured: 1 year after curative treatment
Secondary outcomes (5)
Recurrence free survival
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.
Measured: 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
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.
Measured: From date of enrollment until the date of death from any cause, up to 72 weeks.
Objective response rate after neoadjuvant phase
Tumor assessment in accordance with RECIST1.1 will be performed after neoadjuvant administration.
Measured: Evaluation period is just before curative treatment, up to 4 weeks.
Tumor markers
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.
Measured: 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]
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).
Measured: From the date of enrollment until the date of last administration of study drug, thereafter up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start10 Nov 2017 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Masatoshi Kudo, Kindai University
- Investigators
- Masatoshi Kudo, Professor, Principal investigator, Kindai University Faculty of Medicine, Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337841
- Sponsor's protocol ID
- AURORA study
- Status last verified
- Nov 2017
- First submitted
- 30 Oct 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma With Pembrolizumab Trial (AURORA)
- ClinicalTrials.gov ID
- NCT03337841
- Acronym / sponsor ID
- AURORA study
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Neo adjuvant chemotherapy, Adjuvant chemotherapy, Immune checkpoint inhibitor, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Nov 2017 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 9 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Experimental | Drug: PembrolizumabPembrolizumab 200 mg IV once only in the neoadjuvant phase. Pembrolizumab 200 mg IV every 3 weeks in the adjuvant phase. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: MK-3475, KeytrudaEach 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.) | Drug | Pembrolizumab |
Primary outcome
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.
5 secondary outcomes
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.
Overall survival
Time frame: From date of enrollment until the date of death from any cause, up to 72 weeks.
Objective response rate after neoadjuvant phase
Time frame: Evaluation period is just before curative treatment, up to 4 weeks.
Tumor markers
Time frame: 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]
Time frame: From the date of enrollment until the date of last administration of study drug, thereafter up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masatoshi Kudo, Professor principal investigator
Kindai University Faculty of Medicine, Gastroenterology and Hepatology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Hepatocellular Carcinoma, run by Kindai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kazuomi Ueshima, Lecturer (+81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year recurrence-free survival rate (time frame: 1 year after curative treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2017.