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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05239507
Other study ID # D419CR00025
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date March 12, 2023

Study information

Verified date March 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Considering the treatment landscape with its dynamic algorithms and new approaches of sequencing, it is important to identify patient management patterns and survival outcomes arising from the current standard of care. Based on all these considerations, this multicountry, multicentre, noninterventional, real-world, retrospective study is designed to describe the management patterns, clinical characteristics, possible predictors, and survival outcomes in patients with unresectable HCC. The results of this study might help oncologists in optimal patient selection and sequencing of the systemic therapies.


Description:

Patients with unresectable HCC are an extremely heterogeneous population, with several coexisting risk factors like underlying hepatic dysfunction, extrahepatic metastases, and macrovascular invasion (MVI) posing a challenge for optimum sequencing of the existing, newly approved, and emerging targeted therapies. Real-world studies have identified factors such as performance status, Child-Pugh class, MVI or extrahepatic metastasis and AFP levels, which predict the response to treatment. More than half of patients with HCC present with intermediate or advanced-stage disease (BCLC stage B, C or D) and require palliative care. Very few studies have identified the predictors of survival in advanced HCC and further exploration is warranted to optimize treatment regimen. Systemic therapy based on multi-kinase inhibitors, anti-angiogenesis agents, and immunotherapy have become the cornerstone of advanced HCC management. Despite these advances, patients with HCC still have a poor long-term prognosis of -12 month. Clinical decision making has become challenging in cases with localized but unresectable disease or in the presence of impaired liver function; there are multiple treatment options and selection between them is not supported by direct comparative evidence. Furthermore, disease and patient characteristics seen in clinical practice may be very different from those included in clinical trials; there may be less rigorous follow up and patient counselling resulting in reduced compliance with treatments. Considering the treatment landscape with its dynamic algorithms and new approaches of sequencing, it is important to identify patient management patterns and survival outcomes arising from the current standard of care. Based on all these considerations, this multi-country, multicenter, noninterventional, real-world, retrospective study is designed to describe the management patterns, clinical characteristics, possible predictors, and survival outcomes in patients with unresectable HCC. The results of this study might help oncologists in optimal patient selection and sequencing of the systemic therapies.


Recruitment information / eligibility

Status Completed
Enrollment 1127
Est. completion date March 12, 2023
Est. primary completion date March 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult female or male patients aged =18 years or 'adults' according to the age of majority as defined by the local regulations at index diagnosis 2. Patients or legal representative (unless a waiver is granted) willing and be able to provide informed consent according to local regulations. For deceased patients at study entry, informed consent is not mandatory. 3. Patients with radiologically or histopathologically confirmed diagnosis (at index date) of unresectable BCLC stage B HCC, not considered eligible for initial loco-regional therapya or stage C advanced or metastatic disease, between 01 January 2017 and 31 December 2019. 4. Availability of at least 12 months of follow-up data (from the index date) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis. Exclusion Criteria: 1. Patients with BCLC stage D HCC at index diagnosis 2. Patients with concomitant cancer, at the time of diagnosis of unresectable HCC, except for the nonmetastatic nonmelanoma skin cancers or in situ or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HCC diagnosis.

Study Design


Locations

Country Name City State
Brazil Research Site Porto Alegre Rio Grande Do Sul
Brazil Research Site São Paulo
Egypt Research Site Alexandira
Egypt Research Site Assiut
Egypt Research Site Cairo
Egypt Research Site Menufia
Hong Kong Research Site Hong Kong
India Research Site Faridabad
India Research Site Howrah
India Research Site Kolkata
India Research Site New Delhi
Korea, Republic of Research Site Seoul
Kuwait Research Site Kuwait
Oman Research Site Muscat
Russian Federation Research Site Chelyabinsk
Russian Federation Research Site Moscow
Russian Federation Research Site Saint Petersburg
Saudi Arabia Research Site Makkah
Saudi Arabia Research Site Riyadh
Singapore Research Site Singapore
United Arab Emirates Research Site Abu Dhabi

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Brazil,  Egypt,  Hong Kong,  India,  Korea, Republic of,  Kuwait,  Oman,  Russian Federation,  Saudi Arabia,  Singapore,  United Arab Emirates, 

Outcome

Type Measure Description Time frame Safety issue
Other To describe the survival outcomes associated with different treatment regimens for unresectable HCC Survival outcomes associated with different treatment regimens for unresectable HCC through study completion, an average of 2 year
Other To estimate the effectiveness of different treatment regimens for unresectable HCC including real-world objective response rate (rwORR) Effectiveness of different treatment regimens for unresectable HCC through study completion, an average of 2 year
Other To estimate the effectiveness of different treatment regimens for unresectable HCC including real-world disease control rate (rwDCR) Effectiveness of different treatment regimens for unresectable HCC through study completion, an average of 2 year
Other To investigate the correlation between survival outcomes and clinical characteristics, liver function, and underlying disease in unresectable HCC Identification of potential factors correlating with OS (median OS) among the following clinico-pathological variables: through study completion, an average of 2 year
Primary To describe the OS rate in patients with unresectable HCC including estimates of survival rates at 6, 12, and 18 months and at 2 years OS Kaplan-Meier (KM) curve and survival rates at 6, 12, and 18 months and at 2 years Change from Baseline in Survival Rates at 2 years
Secondary To describe the management patterns in patients with unresectable HCC Percentage of patients receiving standard regimens alone or in combination with other systemic agents in each line of therapy (LOT) through study completion, an average of 2 year
Secondary To describe the demographic and clinical characteristics of patients with unresectable HCC Demographic and clinical characteristics of patients with unresectable HCC At baseline
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