Klinische Studien

IMMULAB

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
2018-001381-42

IMMULAB – A phase II trial of immunotherapy with pembrolizumab in combination with local ablation for patients with early stage hepatocellular carcinoma (HCC)

Status: Active

Purpose / Objectives

Primary Outcome

Overall response rate (ORR) before local Ablation

 

Secondary Outcomes

Time to reccurence (TTR), recurrende free survival and overall survival (OS)
Safety and tolerability
Identification of predictive molecular biomarker

Diagnosis

Early stage hepatocellular carcinoma HCC

Target population

Stage

Early stage hepatocellular carcinoma HCC

Inclusion criteria

Histologically confirmed diagnosis of HCC

Child-Pugh Classification score < 6

Candidate for local ablation (via either RFA of MWA)

High risk patient

No prior system therapy for HCC

Measurable disease based on RECIST

 

Exclusion criteria

Extrahepatic disease

Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

Tumor thrombus involving main trunk of portal vein

Patient is awaiting liver transplantation (LTx)

Prio history of Grade > 2 hepatic encephalopathy

Pericardial effusion, uncontrollable pleura effusion, or clinically significant ascites

Autoimmune disease requiring system Treatment

 

Study design

  • Phase II
  • Multicenter
  • One-arm
  • Open Label

Intervention

Pembrolizumab

 

Documents (password protected)

Responsibilities in overall study

AIO-Studien-gGmbH

National Coordinating Investigator

Dr. med. Marinela Augustin

National Coordinating Investigator

Dr. med. Gabriele Siegler

Study Sites

Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg

Address
Med. Klinik 5 Onkologie/Hämatologie - Klinikum Nürnberg
Klinikum Nürnberg Nord
Prof.-Ernst-Nathan-Str. 1
90419 Nürnberg
Haus: Bau 12

Study office

Status

Active

Principal Investigator

Dr. med. Gabriele Siegler

Deputy of Principal Investigator

  • Dr. med. Marinela Augustin

Contact at Site

 
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