A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization
- Conditions
- Unresectable Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT06503250
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Retrospective Cohort Transarterial Chemoembolization 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. Retrospective Cohort Atezolizumab 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. Retrospective Cohort Bevacizumab 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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.
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.
Trial Locations
- Locations (5)
The Third Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, China
The First Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou City, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
Tianjin First Central Hospital
🇨🇳Tianjin, China
The First Affiliated Hospital of Xian Jiao Tong University
🇨🇳Xi'an City, China