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

NCT06503250 | Completed FDA Drug

• 1 other identifier: ML45337
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  up to approximately 12 months

Secondary Outcomes (6)

• Median Time to Real-World Overall Survival (rwOS)

  up to approximately 3 years

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

  up to approximately 3 years

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

  up to approximately 4 years

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

  up to approximately 4 years

• Percentage of Participants with Surgical Resection

  up to approximately 4 years

Study Arms (1)

Retrospective Cohort

Secondary data from medical records of approx 5 sites across China will be utilized. Patient identification period is between 28 Oct 2020 to 31 Dec 2023. The index date is defined as the earlier date of initiating Atezo+Bev or TACE after the initial diagnosis of unresectable HCC. Baseline period is defined as 60 days prior to the index date. Observation period is defined as the period from the index date until death, latest visit record during retrospective observation period, diagnosis of other primary cancer (except basal cell carcinoma), or 31 March 2024, whichever occurs first.

Drug: Atezolizumab; Drug: Bevacizumab; Radiation: Transarterial Chemoembolization

Interventions

Atezolizumab DRUG

Observational Study

Also known as: Tecentriq

Retrospective Cohort

Bevacizumab DRUG

Observational Study

Also known as: Avastin

Retrospective Cohort

Transarterial Chemoembolization RADIATION

Observational Study

Also known as: TACE

Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will consist of adult patients with unresectable HCC who initiated Atezo+Bev plus TACE between 28 October 2020 and 31 December 2023 from approximately 3-5 study sites in China. Sites will be selected based on geographic representativeness, experience in clinical studies and HCC disease management.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, 510080, China

Location

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, 510630, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Tianjin First Central Hospital

Tianjin, DUMMY_VALUE, China

Location

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, 710061, China

Location

MeSH Terms

Interventions

atezolizumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: July 19, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)