Perioperative Therapy with Durvalumab Plus Tremelimumab for Patients with Resectable Hepatocellular Carcinoma (HCC) - A Phase II Trial (NEOTOMA)

Conditions

Resectable Hepatocellular Carcinoma

Brief summary

The number of ≥ grade 3 adverse events (AEs) or immune related adverse events that leads to treatment cessation

Detailed description

The number of patients who experience a surgical delay due to treatment related adverse events (TRAEs), According to RECIST v1.1 and mRECIST: Objective response rate (ORR), % Viable tumour remaining, Number of resections with negative margins Exploratory Recurrence free survival using RECIST 1.1, Overall survival, Planned analyses include • CITEseq. (N=5) • Multiparameter Flow Cytometry. • T cell receptor sequencing to define T-cell clonal distribution and functional specificity for mutant tumour antigens (n=5). • Multiplex immunohistochemical analysis (IHC) of immune cell populations., Blood samples will be banked for: • TCR sequencing; • Blood immunophenotyping; • Additional blood will be banked for future analyses including cfDNA quantification, Stool will be collected and banked for future correlative analyses

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
The number of ≥ grade 3 adverse events (AEs) or immune related adverse events that leads to treatment cessation	—

Secondary

Measure	Time frame
The number of patients who experience a surgical delay due to treatment related adverse events (TRAEs), According to RECIST v1.1 and mRECIST: Objective response rate (ORR), % Viable tumour remaining, Number of resections with negative margins Exploratory Recurrence free survival using RECIST 1.1, Overall survival, Planned analyses include • CITEseq. (N=5) • Multiparameter Flow Cytometry. • T cell receptor sequencing to define T-cell clonal distribution and functional specificity for mutant tumour antigens (n=5). • Multiplex immunohistochemical analysis (IHC) of immune cell populations., Blood samples will be banked for: • TCR sequencing; • Blood immunophenotyping; • Additional blood will be banked for future analyses including cfDNA quantification, Stool will be collected and banked for future correlative analyses	—

Measure

Time frame

The number of patients who experience a surgical delay due to treatment related adverse events (TRAEs), According to RECIST v1.1 and mRECIST: Objective response rate (ORR), % Viable tumour remaining, Number of resections with negative margins Exploratory Recurrence free survival using RECIST 1.1, Overall survival, Planned analyses include • CITEseq. (N=5) • Multiparameter Flow Cytometry. • T cell receptor sequencing to define T-cell clonal distribution and functional specificity for mutant tumour antigens (n=5). • Multiplex immunohistochemical analysis (IHC) of immune cell populations., Blood samples will be banked for: • TCR sequencing; • Blood immunophenotyping; • Additional blood will be banked for future analyses including cfDNA quantification, Stool will be collected and banked for future correlative analyses

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Countries

Italy, Spain

Outcome results

None listed