Clinical trial NCT06503250: A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization
Official title: Effectiveness and Safety of Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization as Conversion Therapy Among Patients With Initially Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unresectable Hepatocellular Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Median Time to Real-World Progression-Free Survival (rwPFS)
timeFrame: up to approximately 12 months
Secondary outcomes:
measure: Median Time to Real-World Overall Survival (rwOS)
timeFrame: up to approximately 3 years
measure: Median Time to Real-World Overall Response Rate (rwORR)
timeFrame: up to approximately 3 years
measure: Percentage of Participants with Serum Alpha-Fetoprotein (AFP) Reduction
timeFrame: up to approximately 4 years
measure: Percentage of Participants with Prothrombin Induced by the Absence of Vitamin K or Antagonist-II (PIVKA-II) Reduction:
timeFrame: up to approximately 4 years
measure: Percentage of Participants with Surgical Resection
timeFrame: up to approximately 4 years
measure: Percentage of Participants with Adverse Events
timeFrame: up to approximately 4 years
Other outcomes:
Locations:
city: Guangzhou City
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Tianjin
country: China
facility: Tianjin First Central Hospital
city: Xi'an City
country: China
facility: The First Affiliated Hospital of Xian Jiao Tong University
Study officials:
References: