Observational Study Protocol: LIVER-R

Conditions

• Hepatobiliary Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab-based combination therapies in observational study setting — OTHER
  Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).
• Durvalumab-based combination therapies in observational study setting — OTHER
  Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

Study Details

Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multicountry, multicenter, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of durvalumab-based regimens in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, recurrence-free survival, and time to treatment recurrence).

Key Dates

Start date

Mar 16, 2023

Status verified

Dec 2025

Primary completion

Dec 30, 2030

Completion

Dec 30, 2030

Study Design

Enrollment

4,490 participants (estimated)

Arms

• Arm: unresectable hepatocellular carcinoma (uHCC)
  unresectable hepatocellular carcinoma (uHCC)
• Arm: advanced biliary tract cancer (aBTC)
  advanced biliary tract cancer (aBTC)

Primary Outcome Measure

Real-world overall survival (rwOS) [ Time Frame: rwOS will be assessed as OS rates at 6, 12, 24 months (both aBTC and uHCC), and 36 months (uHCC), median OS for a maximum follow-up of 2 and 3 years for aBTC and uHCC, respectively. ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (21)

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