Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aHCC/uHCC | patients with advanced or unresectable HCC (uHCC) treated with STRIDE in Italy according to routine clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STRIDE | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time To Decompensation (TTDec) | 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. | From index date to first hepatic decompensation/study completion, up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time To Worsening (TTWors) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TTDec subgroups | defined for the primary outcome within the first 18 months of treatment by: • Baseline ALBI grade (1 vs 2 or 3) • Cirrhosis at baseline (yes vs no) • Signs of portal hypertension at baseline, i.e., splenomegaly and thrombocytopenia and presence of collateral circulation, or porto-systemic shunts (yes vs no) | From index date to first hepatic decompensation/study completion, up to 30 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study population will be made up of patients with histologically or radiologically confirmed advanced or uHCC not amenable to surgery and/or locoregional therapies, and without previous systemic therapy for HCC who are starting treatment with STRIDE as per routine clinical practice and independently of participation in this study. The study aims to enroll approximately 200 patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center | Contact | +1877240 | 9479 | information.center@astrazeneca.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Active, not recruiting | Ancona | 60126 | Italy | ||
| Research site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
Not provided
Not provided
Not provided
Not provided
| Baseline and every 8 weeks during treatment, up to 30 months |
| Overall Survival (OS) | time from first treatment to death | From index date through study completion, up to 30 months |
| Progression free survival (PFS) | time from first treatment to radiologic evidence of tumor progression or death based on investigator assessment (RECIST v1.1). | From index date until tumor progression, assessed until study completion, up to 30 months |
| Overall response rate (ORR) | proportion of participants with a complete response (CR) or partial response (PR) per RECIST v1.1. | From index date until objective tumor progression, assessed until study completion, up to 30 months |
| Disease Control Rate (DCR) | 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). | From index date until objective tumor progression or date of death, assessed until study completion, up to 30 months |
| Downstaging | Proportion of participants who undergo liver transplant following downstaging with the STRIDE regimen | From index date until study completion, up to 30 months |
| safety | Adverse events: severity, seriousness, causality, action taken with durvalumab, and outcome. | From index date until study completion, up to 33 months |
| Active, not recruiting |
| Bergamo |
| 24129 |
| Italy |
| Research site | Recruiting | Foggia | 71122 | Italy |
| Research site | Active, not recruiting | Meldola | 47014 | Italy |
| Research site | Active, not recruiting | Milan | 20122 | Italy |
| Research site | Active, not recruiting | Milan | 20162 | Italy |
| Research site | Active, not recruiting | Modena | 41124 | Italy |
| Research site | Recruiting | Naples | 80131 | Italy |
| Research site | Active, not recruiting | Padova | 35100 | Italy |
| Research site | Active, not recruiting | Palermo | 90127 | Italy |
| Research site | Active, not recruiting | Pisa | 56126 | Italy |
| Research site | Active, not recruiting | Pozzuoli | 80078 | Italy |
| Research site | Active, not recruiting | Roma | 00168 | Italy |
| Research site | Active, not recruiting | Rozzano | 20089 | Italy |
| Research site | Active, not recruiting | Torino | 10126 | Italy |
| Research site | Active, not recruiting | Verona | 37134 | Italy |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided