check_circleStudy Completed

Hepatocellular cancer

Bayer Identifier:

22241

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Real World Treatment Patterns After Use of Atezolizumab and Bevacizumab Combination Therapy in Patients with Hepatocellular Cancer

Trial purpose

This study is a retrospective cohort analysis of patients diagnosed with HCC and with use of atezo+bev combination as first observed therapy between June 1, 2020,
and June 30, 2022.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Patients with ≥1 claim of atezolizumab and ≥1 claim of bevacizumab in LRx or Dx during the study period
    - Patients with ≥1 claim of atezolizumab (HCPCS J9022 or C9483; NDC 50242-917) and bevacizumab (HCPCS J9035; NDC 50242-060 or 50242-061) on the same day during the index period (6/1/2020 to 6/30/2022). The index date = date of initiation of combination therapy.
    - Patients with ≥1 claim with a HCC diagnosis code (ICD10: C22.; ICD9: 155.) in any position in all available data prior to index date (incl. index date)
    - Patients without any systemic HCC therapy (sorafenib, regorafenib, lenvatinib, cabozantinib, nivolumab, pembrolizumab, ramucirumab, ipilimumab, and chemotherapies) in the 3-month pre-index period (incl. index date)
    - Patients without any non-TACE chemotherapy of interest in the 3-month pre-index period
    - Aged ≥18 years on the index date
    - Eligibility in LRx and Dx in the 3 months prior to the index date, defined as
    a) at least 1 pharmacy claim ≥3 months prior to the index date in LRx AND
    b) at least 1 medical claim ≥3 months prior to the index date in Dx
    - Pharmacy and provider stability for 3-month pre-index -- any pharmacy/provider the patient visited during the 12-month pre-index period and anytime post index
    - Eligibility in LRx and Dx in the 2 months following the index date, defined as
    a) at least 1 pharmacy claim ≥2 months after the index date in LRx AND
    b) at least 1 medical claim ≥2 months after the index date in Dx
    - Pharmacy and provider stability for 2-month post-index -- any pharmacy/provider the patient visited during the 12-month pre-index period and anytime post index
  • - Patients with a diagnosis of other primary cancer before index date (incl. index date)

Trial summary

Enrollment Goal
825
Trial Dates
April 2022 - June 2022
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Primary Outcome

  • Percentage of patients receiving any other systemic HCC therapy after first observed (index) atezo+bev in HCC patients treated in real-world clinical practice
    date_rangeTime Frame:
    Retrospective analysis between June 1, 2020, and June 30, 2022
  • Describe which therapies are used after index atezo+bev among HCC patients
    Including, but not limited to, the proportion of patients receiving sorafenib, regorafenib, lenvatinib, cabozantinib, and any other systemic HCC therapy (including nivolumab, pembrolizumab, ramucirumab, ipilimumab) after index atezo+bev
    date_rangeTime Frame:
    Retrospective analysis between June 1, 2020, and June 30, 2022

Secondary Outcome

  • Proportion of patients switching at different timepoints (i.e., at 3-, 6-, 9-, and 12-months post-index and over the entire study period)
    date_rangeTime Frame:
    Retrospective analysis between June 1, 2020, and June 30, 2022
  • Baseline characteristics of 3 subgroups of HCC patients:
    a. All patients receiving index atezo+bev; b. Patients not switching to another therapy after index atezo+bev (non-switchers); c. Patients switching to subsequent HCC therapy after index atezo+bev (switchers);
    date_rangeTime Frame:
    Retrospective analysis between June 1, 2020, and June 30, 2022
  • Treatment sequence for all treatments received post index atezo+bev
    date_rangeTime Frame:
    Retrospective analysis between June 1, 2020, and June 30, 2022
  • time to discontinuation (TTD) for index atezo+bev and time to the first post atezo+bev systemic HCC therapy for switchers
    date_rangeTime Frame:
    Retrospective analysis between June 1, 2020, and June 30, 2022

Trial design

Real World Treatment Patterns After Use of Atezolizumab and Bevacizumab Combination Therapy in Patients with Hepatocellular Cancer
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A