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Completed

NCT Number: NCT06503250

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

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 unresectable hepatocellular carcinoma (HCC) in real-world clinical practice in China. Eligible patients diagnosed with unresectable HCC initiating the Atezo+Bev and TACE between 28 October 2020 and 31 December 2023 will be included in this study.

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Key information

Conditions

Unresectable Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

Observational Study

Other names: Tecentriq

Bevacizumab

Drug

Observational Study

Other names: Avastin

Transarterial Chemoembolization

Radiation

Observational Study

Other names: TACE

Primary outcomes

  1. Median Time to Real-World Progression-Free Survival (rwPFS)

    Time frame: up to approximately 12 months

    rwPFS is defined as time from the index date to the first evidence of clinician-assessed progressive disease (may include but are not limited to local tumor progression, disease recurrence, new metastasis, or clinical progression anchored by clinicians) or death from any cause.

Secondary outcomes

  1. Median Time to Real-World Overall Survival (rwOS)

    Time frame: up to approximately 3 years

    rwOS is defined as time from the index date to death from any cause.

  2. Median Time to Real-World Overall Response Rate (rwORR)

    Time frame: up to approximately 3 years

    rwORR is defined as the percentage of patients who achieved complete response (CR) or partial response (PR) after the initiation of both Atezo+Bev and TACE among patients with at least one response assessment result after the initiation of both Atezo+Bev and TACE, with reference to the assessment of tumor lesions within 60 days prior to the later initiation of Atezo+Bev or TACE.

  3. Percentage of Participants with Serum Alpha-Fetoprotein (AFP) Reduction

    Time frame: up to approximately 4 years

    AFP reduction is defined as > 50% reduction in AFP level after 3 months (± 4 weeks) of the later initiation of Atezo+Bev or TACE.

  4. Percentage of Participants with Prothrombin Induced by the Absence of Vitamin K or Antagonist-II (PIVKA-II) Reduction:

    Time frame: up to approximately 4 years

    PIVKA-II reduction is defined as > 50% reduction in PIVKA-II level after 3 months (± 4 weeks) of the later initiation of Atezo+Bev or TACE.

  5. Percentage of Participants with Surgical Resection

    Time frame: up to approximately 4 years

    Conversion rate (surgical resection) is defined as the percentage of patients who underwent surgical resection of tumor among patients who completed the Atezo+Bev plus TACE treatment by the end of observation period.

  6. Percentage of Participants with Adverse Events

    Time frame: up to approximately 4 years

    The adverse events of interest include liver function abnormality, renal function abnormality, hemorrhage, hypertension, hepatitis virus reactivation and immune-related adverse events.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Effectiveness and Safety of Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization as Conversion Therapy Among Patients With Initially Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice in China

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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