Hepatocellular Carcinoma
Conditions
Brief summary
Italian multicenter observational study to evaluate time to clinical hepatic decompensation, quality of life, effectiveness, and safety of tremelimumab plus durvalumab in patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic treatment.
Interventions
DRUGSTRIDE
Tremelimumab 300 mg as a single dose administered in combination with durvalumab 1500 mg at Cycle 1/Day 1, followed by durvalumab monotherapy every 4 weeks.
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* \- Signed informed consent. * Age ≥ 18 years. * Histologically or radiologically confirmed diagnosis of advanced or unresectable HCC. * BCLC B or C HCC. * Child-Pugh A (score 5 or 6). * Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1. * Planned first-line treatment of advanced/uHCC with STRIDE.
Exclusion criteria
* \- Any previous line of systemic therapy for HCC. * Any prior or concomitant immunotherapy. * Prior allogeneic organ or bone marrow transplant. * Documented active or previous GI bleeding within the previous 12 months. * Main trunk portal vein thrombosis. * Autoimmune disease requiring treatment with immunosuppressive medication. * Known hypersensitivity to the active substance or to any of the STRIDE excipients. * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time To Decompensation (TTDec) | From index date to first hepatic decompensation/study completion, up to 30 months | time from index date (start of new treatment) to the first occurrence of events such as ascites of any grade according to the European Association for the Study of the Liver (EASL) classification, hepatic encephalopathy of any grade according to West Haven classification, variceal hemorrhage, or jaundice (total bilirubin \>3 mg/dL). In Child-Pugh (CP)-A participants with a score of 6 at index date, TTDec is defined as the time from index date to any worsening in ascites, hepatic encephalopathy, variceal hemorrhage, or jaundice (defined as an increase in total bilirubin to greater than 3 mg/dL or a worsening of more than 1.0 mg/dL from index date). At the time of decompensation (± 30 days) a CT scan should be performed to exclude worsening of liver function due to tumor progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Downstaging | From index date until study completion, up to 30 months | Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen |
| Time To Worsening (TTWors) | Baseline and every 8 weeks during treatment, up to 30 months | Time To Worsening (TTWors) based on the EORTC QLQ-C30 and QLQ-HCC18 PROs within the first 18 months of treatment. TTWors is the time from first treatment to first clinically meaningful deterioration confirmed at a subsequent visit/assessment or death from any cause. A clinically meaningful change (deterioration or improvement) is defined as an absolute change ≥ 10 points in total score from index date. |
| Overall Survival (OS) | From index date through study completion, up to 30 months | time from first treatment to death |
| Progression free survival (PFS) | From index date until tumor progression, assessed until study completion, up to 30 months | time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1). |
| Overall response rate (ORR) | From index date until objective tumor progression, assessed until study completion, up to 30 months | proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1. |
| safety | From index date until study completion, up to 33 months | Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome. |
| Disease Control Rate (DCR) | From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months | proportion of participants with a CR, PR, or stable disease (SD) per RECIST v1.1. (stable disease needs to be maintained for a minimum of 8 weeks to be included in the DCR). |
Countries
Italy
Contacts
CONTACTAstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
Outcome results
None listed