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advanced biliary tract cancer (aBTC) for Hepatobiliary Cancer (LIVER-R Trial)

N/A
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rwttr will be assessed as median ttr for a maximum follow-up of 2 years (abtc) or 3 years (uhcc).
Awards & highlights

LIVER-R Trial Summary

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).

LIVER-R Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~rwdot will be assessed as median dot for a maximum follow-up of 2 years (abtc) or 3 years (uhcc).
This trial's timeline: 3 weeks for screening, Varies for treatment, and rwdot will be assessed as median dot for a maximum follow-up of 2 years (abtc) or 3 years (uhcc). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Real-world overall survival (rwOS)
Secondary outcome measures
Clinically significant events (CSEs) of interest leading to a medical intervention
Patient demographic and clinical characteristics
Percentage of patients receiving each treatment regimen
+6 more

LIVER-R Trial Design

2Treatment groups
Experimental Treatment
Group I: unresectable hepatocellular carcinoma (uHCC)Experimental Treatment1 Intervention
unresectable hepatocellular carcinoma (uHCC)
Group II: advanced biliary tract cancer (aBTC)Experimental Treatment1 Intervention
advanced biliary tract cancer (aBTC)

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,602,491 Total Patients Enrolled
ICON plcIndustry Sponsor
80 Previous Clinical Trials
20,656 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2993 spots leftby Dec 2029