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

NCT ID: NCT06503250

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-19

Study Completion Date

2024-11-27

Brief Summary

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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.

Detailed Description

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Conditions

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Unresectable Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Atezolizumab

Intervention Type DRUG

Observational Study

Bevacizumab

Intervention Type DRUG

Observational Study

Transarterial Chemoembolization

Intervention Type RADIATION

Observational Study

Interventions

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Atezolizumab

Observational Study

Intervention Type DRUG

Bevacizumab

Observational Study

Intervention Type DRUG

Transarterial Chemoembolization

Observational Study

Intervention Type RADIATION

Other Intervention Names

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Tecentriq Avastin TACE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, , China

Site Status

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, , China

Site Status

Zhongshan Hospital Fudan University

Shanghai, , China

Site Status

Tianjin First Central Hospital

Tianjin, , China

Site Status

The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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ML45337

Identifier Type: -

Identifier Source: org_study_id

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