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

Roche

Status: Completed

Conditions: Unresectable Hepatocellular Carcinoma

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06503250

ML45337

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

113 participants in 1 patient group

Retrospective Cohort

Description:

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.

Treatment:

Drug: Atezolizumab

Radiation: Transarterial Chemoembolization

Drug: Bevacizumab