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This is a multicenter,retrospective study to explore the effectiveness and safety of Atezo/Bev plus hepatic artery infusion chemotherapy (HAIC) among adult patients with high-risk HCC in real-world clinical practice in China. Eligible patients diagnosed with high-risk HCC initiating the study treatment of interest between 28 October 2020 and 31 June 2025 will be included in this study. Secondary data from medical records of approximately 10 sites across China will be utilized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX+TA | Experimental | FOLOFOX-HAIC plus Atezolizumab and Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab & Bevacizumab | Drug | Atezolizumab 1200mg & Bevacizumab 15mg/kg Q3W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | defined as time from index date to death from any cause. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Real-world progression-free survival (rwPFS) | defined as time from index date to the earlier of clinician-anchored 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. | 6 months |
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Inclusion criteria:
Aged ≥ 18 years at the initiation of Atezo/Bev plus HAIC
Initiating Atezo/Bev between 28 October 2020 and 31 June 2025
Diagnosed with high-risk HCC as evidenced clinically or by radiology, histology or cytology before or at the initiation of Atezo/Bev plus HAIC. The evidence of being diagnosed as "high-risk" was based on the IMbrave 150, including any of the following:
At least one visit record after the initiation of Atezo/Bev plus HAIC
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
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| FOLFOX-HAIC |
| Procedure |
hepatic artery infusion chemotherapy of oxaliplatin, leucovorin, and fluorouracil |
|
| Time to discontinuation (TTD) |
defined as time from the initiation to discontinuation of Atezo/Bev plus HAIC. |
| 6 months |
| Time to next treatment (TTNT) | defined as time from the initiation of Atezo/Bev plus HAIC to the initiation of next systemic treatment. | 6 months |
| Serum alpha-fetoprotein (AFP) reduction | defined as > 50% reduction in AFP level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC. | 6 months |
| Prothrombin induced by the absence of vitamin K or antagonist- II (PIVKA-II) reduction | defined as > 50% reduction in PIVKA-II level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC. | 6 months |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Safety | 30 days |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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