Status:

COMPLETED

A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Unresectable Hepatocellular Carcinoma

Eligibility:

All Genders

18+ years

Brief Summary

This is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of Atezo+Bev plus Transarterial Chemoembolization (TACE) among adult patients with unresectabl...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Initiating both Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 regardless of sequencing, number of doses/cycles, and type of TACE
  • At least one dose of Atezo+Bev and one cycle of TACE spaced no longer than 4 weeks
  • Diagnosed with HCC and considered as unresectable by any of the below criteria:
  • Predicted insufficient future liver remnant volume (FLRV) after liver resection, OR
  • Predicted unattainable safe negative tumor margin resection, i.e., R0 resection, OR
  • "Unresectable" directly documented in the medical records
  • Exclusion Criteria:
  • No visit record after initiating both Atezo+Bev and TACE
  • Treated with other systemic therapy or resection against HCC
  • Diagnosed with concomitant cancer except for basal cell carcinoma
  • Advanced portal vein tumor thrombosis (PVTT) as defined by: Grade Vp 4, Cheng's Classification Type III or IV, or presence of a tumor thrombus in the main trunk of the portal vein, a portal vein branch contralateral to the primarily involved lobe, or superior mesenteric vein
  • China Liver Cancer (CNLC) Stage IIIb, or history of extrahepatic metastasis
  • Terminal-stage HCC

Exclusion

    Key Trial Info

    Start Date :

    July 19 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    November 27 2024

    Estimated Enrollment :

    113 Patients enrolled

    Trial Details

    Trial ID

    NCT06503250

    Start Date

    July 19 2024

    End Date

    November 27 2024

    Last Update

    March 21 2025

    Active Locations (5)

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    Page 1 of 2 (5 locations)

    1

    The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, China, 510080

    2

    The Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, China, 510630

    3

    Zhongshan Hospital Fudan University

    Shanghai, China, 200032

    4

    Tianjin First Central Hospital

    Tianjin, China, DUMMY_VALUE