Unresectable Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGAtezolizumab
Observational Study
DRUGBevacizumab
Observational Study
RADIATIONTransarterial Chemoembolization
Observational Study
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Real-World Progression-Free Survival (rwPFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Real-World Overall Response Rate (rwORR) | 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. |
| Percentage of Participants with Serum Alpha-Fetoprotein (AFP) Reduction | 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. |
| Median Time to Real-World Overall Survival (rwOS) | up to approximately 3 years | rwOS is defined as time from the index date to death from any cause. |
| Percentage of Participants with Surgical Resection | 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. |
| Percentage of Participants with Adverse Events | 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. |
| Percentage of Participants with Prothrombin Induced by the Absence of Vitamin K or Antagonist-II (PIVKA-II) Reduction: | 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. |
Countries
China
Outcome results
None listed