Study 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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Products

Stivarga (Regorafenib, BAY73-4506)

Accepts Healthy Volunteer

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
Time 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
Time 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)
Time 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);
Time Frame:
Retrospective analysis between June 1, 2020, and June 30, 2022
Treatment sequence for all treatments received post index atezo+bev
Time 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
Time 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