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

Hoffmann-La Roche113 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

113

Conditions

Unresectable Hepatocellular Carcinoma

Interventions

AtezolizumabDRUG

Observational Study

BevacizumabDRUG

Observational Study

Transarterial ChemoembolizationRADIATION

Observational Study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. 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 2. At least one dose of Atezo+Bev and one cycle of TACE spaced no longer than 4 weeks 3. 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: 1. No visit record after initiating both Atezo+Bev and TACE 2. Treated with other systemic therapy or resection against HCC 3. Diagnosed with concomitant cancer except for basal cell carcinoma 4. 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 5. China Liver Cancer (CNLC) Stage IIIb, or history of extrahepatic metastasis 6. Terminal-stage HCC

Locations (5)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

Zhongshan Hospital Fudan University

Shanghai, China

Tianjin First Central Hospital

Tianjin, China

Outcomes

Primary Outcomes

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

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.

Time frame: up to approximately 12 months

Secondary Outcomes

Median Time to Real-World Overall Survival (rwOS)

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

Time frame: up to approximately 3 years

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

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.

Time frame: up to approximately 3 years

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

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

Time frame: up to approximately 4 years

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

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.

Time frame: up to approximately 4 years

Percentage of Participants with Surgical Resection

Data from ClinicalTrials.gov

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