A PHASE IB/II, OPEN-LABEL, MULTICENTER, RANDOMIZED PLATFORM STUDY EVALUATING THE EFFICACY AND SAFETY OF NEOADJUVANT IMMUNOTHERAPY COMBINATIONS IN PATIENTS WITH SURGICALLY RESECTABLE HEPATOCEULLULAR CARCINOMA (MORPHEUS-NEO HCC)

Conditions

Hepatocellular Carcinoma (Morpheus-Neo HCC)

Brief summary

MPR rate

Detailed description

pCR rate, RFS, EFS, OS, ORR, Proportion of participants downstaged to within Milan criteria (for participants beyond criteria at randomization), R0 resection rate (proportion of resected participants obtaining an R0 resection), Incidence, nature, and severity of adverse events, serious adverse events, and immune-related adverse events [severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0); severity of cytokine release syndrome (CRS) determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Scale], Proportion of participants with delayed or canceled surgery due to treatment-related adverse events, as well as length of surgical delay, duration of surgery, length of hospital stay, surgical approach, extent of surgery, intraoperative blood loss, and need for intraoperative blood transfusion, Post-operative surgical complication rates according to the Clavien- Dindo surgical classification, Post-operative mortality

Related papers

No related papers found yet.

Interventions

DRUGTecentriq 1

DRUG200 mg concentrate for solution for infusion

DRUGAvastin 25 mg/ml concentrate for solution for infusion.

DRUGTiragolumab

DRUGRO7247669

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MPR rate	—

Secondary

Measure	Time frame
pCR rate, RFS, EFS, OS, ORR, Proportion of participants downstaged to within Milan criteria (for participants beyond criteria at randomization), R0 resection rate (proportion of resected participants obtaining an R0 resection), Incidence, nature, and severity of adverse events, serious adverse events, and immune-related adverse events [severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0); severity of cytokine release syndrome (CRS) determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Scale], Proportion of participants with delayed or canceled surgery due to treatment-related adverse events, as well as length of surgical delay, duration of surgery, length of hospital stay, surgical approach, extent of surgery, intraoperative blood loss, and need for intraoperative blood transfusion, Post-operative surgical complication rates according to the C	—

Measure

Time frame

pCR rate, RFS, EFS, OS, ORR, Proportion of participants downstaged to within Milan criteria (for participants beyond criteria at randomization), R0 resection rate (proportion of resected participants obtaining an R0 resection), Incidence, nature, and severity of adverse events, serious adverse events, and immune-related adverse events [severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0); severity of cytokine release syndrome (CRS) determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading Scale], Proportion of participants with delayed or canceled surgery due to treatment-related adverse events, as well as length of surgical delay, duration of surgery, length of hospital stay, surgical approach, extent of surgery, intraoperative blood loss, and need for intraoperative blood transfusion, Post-operative surgical complication rates according to the C

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Countries

Austria, France, Germany, Spain

Outcome results

None listed