Status:

COMPLETED

OREIOS International Study

Lead Sponsor:

AstraZeneca

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18+ years

Brief Summary

Considering the treatment landscape with its dynamic algorithms and new approaches of sequencing, it is important to identify patient management patterns and survival outcomes arising from the current...

Detailed Description

Patients with unresectable HCC are an extremely heterogeneous population, with several coexisting risk factors like underlying hepatic dysfunction, extrahepatic metastases, and macrovascular invasion ...

Eligibility Criteria

Inclusion

  • Adult female or male patients aged ≥18 years or 'adults' according to the age of majority as defined by the local regulations at index diagnosis
  • Patients or legal representative (unless a waiver is granted) willing and be able to provide informed consent according to local regulations. For deceased patients at study entry, informed consent is not mandatory.
  • Patients with radiologically or histopathologically confirmed diagnosis (at index date) of unresectable BCLC stage B HCC, not considered eligible for initial loco-regional therapya or stage C advanced or metastatic disease, between 01 January 2017 and 31 December 2019.
  • Availability of at least 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis.

Exclusion

  • Patients with BCLC stage D HCC at index diagnosis
  • Patients with concomitant cancer, at the time of diagnosis of unresectable HCC, except for the nonmetastatic nonmelanoma skin cancers or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HCC diagnosis.

Key Trial Info

Start Date :

February 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 12 2023

Estimated Enrollment :

1127 Patients enrolled

Trial Details

Trial ID

NCT05239507

Start Date

February 1 2022

End Date

March 12 2023

Last Update

March 13 2024

Active Locations (21)

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Page 1 of 6 (21 locations)

1

Research Site

Porto Alegre, Rio Grande do Sul, Brazil, 90560030

2

Research Site

São Paulo, Brazil, 1246000

3

Research Site

Alexandira, Egypt

4

Research Site

Asyut, Egypt