Clinical trial · Interventional
Pembrolizumab as Neoadjuvant Treatment in HCC
Neoadjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma With Pembrolizumab Trial (AURORA)
NCT03337841CI-TRIAL-00030273unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pembrolizumab
- description
- Pembrolizumab 200 mg IV once only in the neoadjuvant phase. Pembrolizumab 200 mg IV every 3 weeks in the adjuvant phase.
- interventionNames
- Drug: Pembrolizumab
Primary outcomes (1)
- measure
- One-year recurrence-free survival rate
- timeFrame
- 1 year after curative treatment
- description
- One-year recurrence-free survival rate is defined as the recurrence-free survival rate 1year after curative treatment.
Secondary outcomes (5)
- measure
- Recurrence free survival
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.