Clinical investigation evaluating safety and efficacy of selective intra-arterial 166Holmium radiation therapy in combination with atezolizumab and bevacizumab for non resectable Hepatocellular carcinoma (HOLMBRAVE)

Conditions

Non resectable Hepatocellular carcinoma (HCC)

Brief summary

• Objective response rate (complete or partial response) at 6 months after 166Holmium SIRT according to mRECIST on contrast enhanced imaging (CT-scan and/or MRI)

Detailed description

• Objective Response Rate (ORR), PFS and OS at 12 weeks, at 6- and 12-months according to mRECIST criteria, but also itRECIST criteria., • Type, frequency and severity of treatment related adverse events (irAEs) and adverse device effects (ADEs)., • Identifying of predictive biomarkers of tumor response and adverse events (imaging and biological), • Determination of the immune checkpoints upregulated upon Atezolizumab/Bevacizumab therapy within tumors of primary and secondary resistant patients., • Assessment of the Increase in tumor infiltrating CD3+ lymphocytes, CD8+CD69+/FOXP3+ICOS+ T-cells, PDL1 expression, and the proportion of activated cells (CD80, CD86, HLA-II on CD16+, CD32+ and CD64+ myeloid cells)., • Assessment of the impact on angiogenic factors such as Tie2, Angiopoietine, VEGF, on both tumor and blood samples.

Related papers

No related papers found yet.

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGPulmocis 2 mg trousse pour préparation radiopharmaceutique

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Objective response rate (complete or partial response) at 6 months after 166Holmium SIRT according to mRECIST on contrast enhanced imaging (CT-scan and/or MRI)	—

Secondary

Measure	Time frame
• Objective Response Rate (ORR), PFS and OS at 12 weeks, at 6- and 12-months according to mRECIST criteria, but also itRECIST criteria., • Type, frequency and severity of treatment related adverse events (irAEs) and adverse device effects (ADEs)., • Identifying of predictive biomarkers of tumor response and adverse events (imaging and biological), • Determination of the immune checkpoints upregulated upon Atezolizumab/Bevacizumab therapy within tumors of primary and secondary resistant patients., • Assessment of the Increase in tumor infiltrating CD3+ lymphocytes, CD8+CD69+/FOXP3+ICOS+ T-cells, PDL1 expression, and the proportion of activated cells (CD80, CD86, HLA-II on CD16+, CD32+ and CD64+ myeloid cells)., • Assessment of the impact on angiogenic factors such as Tie2, Angiopoietine, VEGF, on both tumor and blood samples.	—

Measure

Time frame

• Objective Response Rate (ORR), PFS and OS at 12 weeks, at 6- and 12-months according to mRECIST criteria, but also itRECIST criteria., • Type, frequency and severity of treatment related adverse events (irAEs) and adverse device effects (ADEs)., • Identifying of predictive biomarkers of tumor response and adverse events (imaging and biological), • Determination of the immune checkpoints upregulated upon Atezolizumab/Bevacizumab therapy within tumors of primary and secondary resistant patients., • Assessment of the Increase in tumor infiltrating CD3+ lymphocytes, CD8+CD69+/FOXP3+ICOS+ T-cells, PDL1 expression, and the proportion of activated cells (CD80, CD86, HLA-II on CD16+, CD32+ and CD64+ myeloid cells)., • Assessment of the impact on angiogenic factors such as Tie2, Angiopoietine, VEGF, on both tumor and blood samples.

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Countries

France

Outcome results

None listed