A randomized open-label phase II study on the effect of durvalumab and tremelimumab combined with personalized SIRT (p-SIRT), standard-dose SIRT (sd-SIRT) or immunotherapy followed by on-demand loco-regional SIRT (od-SIRT) in non-resectable hepatocellular carcinoma (HCC) patients

Conditions

hepatocellular carcinoma

Brief summary

Objective Response Rate (ORR compared to SIRT historical control)

Detailed description

Overall survival (OS), Progression-free survival (PFS), Complete response rate (CRR), Disease control rate (DCR), Duration of response (DoR), Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥30 days for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR); separately for patients in Arm A and Arm B, Time to locally/locoregional untreatable progression (TTuP), defined as time from randomization to occurrence of any of the following conditions: progression which would require targeting of more than 3 pretreated lesions as determined by the latest staging investigation, progression occurring due to diffuse tumor growth, occurrence of vascular invasion, occurrence of extrahepatic spread, worsening of liver function to Child-Pugh score 8 or higher, Time to stage progression (defined as time from randomization to disease progression to BCLC C), To assess the quality of life (QoL), as determined by the EORTC QLQ-C30 and EORTC QLQ-HCC18 questionnaires.

Related papers

No related papers found yet.

Interventions

DRUGTREMELIMUMAB

DRUGDURVALUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR compared to SIRT historical control)	—

Secondary

Measure	Time frame
Overall survival (OS), Progression-free survival (PFS), Complete response rate (CRR), Disease control rate (DCR), Duration of response (DoR), Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥30 days for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR); separately for patients in Arm A and Arm B, Time to locally/locoregional untreatable progression (TTuP), defined as time from randomization to occurrence of any of the following conditions: progression which would require targeting of more than 3 pretreated lesions as determined by the latest staging investigation, progression occurring due to diffuse tumor growth, occurrence of vascular invasion, occurrence of extrahepatic spread, worsening of liver function to Child-Pugh score 8 or higher, Time to stage progression (defined as time	—

Measure

Time frame

Overall survival (OS), Progression-free survival (PFS), Complete response rate (CRR), Disease control rate (DCR), Duration of response (DoR), Time to deterioration of liver function, defined as time from randomization to worsening of CTCAE grade compared with baseline and persisting for ≥30 days for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and international normalized ratio (INR); separately for patients in Arm A and Arm B, Time to locally/locoregional untreatable progression (TTuP), defined as time from randomization to occurrence of any of the following conditions: progression which would require targeting of more than 3 pretreated lesions as determined by the latest staging investigation, progression occurring due to diffuse tumor growth, occurrence of vascular invasion, occurrence of extrahepatic spread, worsening of liver function to Child-Pugh score 8 or higher, Time to stage progression (defined as time

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Countries

Germany, Italy

Outcome results

None listed