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Observational Study Protocol: LIVER-R

NCT06252753 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2026-08-13

No results posted yet for this study

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 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).

Conditions

  • Hepatobiliary Cancers

Interventions

OTHER

Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including STRIDE (Single Tremelimumab Regular Interval Durvalumab), will be collected).

OTHER

Durvalumab-based combination therapies in observational study setting

Data on patients who initiated durvalumab-based regimens, including durvalumab + chemotherapy combinations (e.g., Durvalumab + GemCis etc.) will be collected.

OTHER

Non Durvalumab-based therapies in observational study setting

Data on patients who initiated non durvalumab-based regimens, including LRT alone or LRT followed by systemic therapies, will be collected.

OTHER

Durvalumab-based combination therapies in observational study settings

Data on patients who initiated durvalumab-based regimens in combination with LRT, will be collected

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2030-12-30
Completion
2030-12-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Norway
  • Portugal
  • Puerto Rico
  • Romania
  • Saudi Arabia
  • Singapore
  • Spain
  • Switzerland
  • Taiwan
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06252753 on ClinicalTrials.gov