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.
• Non Durvalumab-based therapies in observational study setting — OTHER
  Data on patients who initiated non durvalumab-based regimens, including LRT alone or LRT followed by systemic therapies, will be collected.
• Durvalumab-based combination therapies in observational study settings — OTHER
  Data on patients who initiated durvalumab-based regimens in combination with LRT, 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 multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without 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 regimens (durvalumab-based or otherwise) 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, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence).

Key Dates

First listed

Feb 12, 2024

Start date

Dec 19, 2023

Status verified

Aug 2026

Primary completion

Dec 30, 2030

Completion

Dec 30, 2030

Study Design

Enrollment

4,000 participants (estimated)

Arms

• Arm: unresectable hepatocellular carcinoma (uHCC)
  advanced uHCC patients who had not received prior systemic therapy and were not eligible for LRT, as well as those who had progressed following LRT, and who have received a durvalumab-based regimen
• Arm: advanced biliary tract cancer (aBTC)
  patients with advanced BTC (aBTC) who are not eligible for resection and who have received a durvalumab-based regimen
• Arm: eeHCC
  uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive LRT alone or LRT followed by systemic therapy within 60 days (if administered in combination, LRT must be received first)
• Arm: EMERALD
  uHCC patients with liver-confined disease not amenable to curative treatment but amenable to LRT who receive durvalumab-based regimens in combination with LRT (durvalumab and LRT are given within 28 days of each other, regardless of order)

Primary Outcome Measure

Real-world overall survival (rwOS) in all participants [ Time Frame: rwOS will be assessed as OS rates at 6, 12, 18, 24, and 36 months, as applicable per the type of hepatobiliary cancer; median OS for a minimum follow-up of 2 years. ]

Central Contacts

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

Locations (24)