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This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC.
Standard treatments provide limited benefits for patients with intermediate or advanced hepatocellular carcinoma (HCC). Recently, recommendations on multimodal treatment regimens for patients with locally advanced HCC have attracted much attention. Therefore, this retrospective research was designed to evaluate the clinical outcomes of TACE alone or in combination with immune and targeted therapy in the primary treatment for patients with intermediate to advanced stage HCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE group | Patients included in the study underwent either conventional TACE (cTACE) or drug-eluting beads TACE (DEB-TACE) procedures performed by experienced interventional radiologists, taking into account tumor burden, patient tolerance, and individual preferences. |
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| Combination group | Systemic treatment commenced within one month after the initial TACE procedure, depending on the proper liver function. Anti-angiogenic agents involved in this study mainly comprised multikinase tyrosine kinase inhibitors. ICIs included therapies targeting programmed cell death protein 1 and its ligands. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transarterial chemoembolization | Drug | A 5-French RH catheter was then introduced to the celiac artery, superior mesenteric and artery common hepatic artery for angiography to determine tumor location, quantity, size, and vascularity. After confirmation by C-arm cone-beam computed tomography (CBCT), chemoembolization was administered by superselective catheterization of the branches of the tumor-feeding arteries using a 2.8-French coaxial microcatheter. For cTACE, oxaliplatin, raltitrexed and an emulsion containing idarubicin and ethiodized oil were infused for over 20 minutes, followed by combined embolization with blank embolic microspheres. For DEB-TACE, DC/LC Beads® (Biocompatibles, Farnham, Surrey, UK), as drug carriers and embolic materials, were loaded with doxorubicin hydrochloride and mixed with nonionic contrast medium. Real-time assessment of embolization was performed with the assistance of CBCT. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) per mRECIST | The duration from treatment initiation to PD in patients who cannot undergo surgery, or to the date of postoperative relapse in patients who receive surgery, or death for any reason, whichever occurs first (according to mRECIST). | 12-48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12 months PFS rate | The percentage of patients who have not progressed or relapsed or death at the 12 month time point since the first time of treatment. | 12 months |
| Overall survival (OS) | The duration from treatment initiation to death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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patients with treatment-naive intermediate or advanced HCC who received with TACE alone or the combination therapy (TACE plus antiangiogenic agents with or without ICIs) at our institution
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Medical College of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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| Systemic treatment | Other | sorafenib (Bayer HealthCare, Berlin, Germany), lenvatinib (Eisai, Tokyo, Japan), apatinib (Hengrui Pharmaceuticals, Lianyungang, China) and donafenib (Zelgen Biopharmaceuticals, Suzhou, China), while a minority of patients received bevacizumab (Innovent Biologics, Suzhou, China). sintilimab (Innovent Biologics, Suzhou, China), toripalimab (Junshi Biosciences, Suzhou, China), camrelizumab (Hengrui Pharmaceuticals, Lianyungang, China), tislelizumab (BeiGene, Shanghai, China), pembrolizumab (Merck Sharp & Dohme, NewJersey, USA), nivolumab (Bristol Myers Squibb, New York, USA), atezolizumab (Roche, Basel, Switzerland) and envafolimab (Alphamab Biopharmaceuticals, Suzhou, China). |
|
| 24-48 months |
| Objective Response Rate (ORR) per mRECIST | The proportion of complete response or partial response as optimal response among all treated patients according to mRECIST. | 12-48 months |
| Disease Control Rate (DCR) per mRECIST | The proportion of complete response, partial response or stable disease as optimal response among all treated patients according to mRECIST. | 12-48 months |
| Adverse events (AEs) | The incidence, relationship with study drugs, and severity level of all adverse events (AEs) according to CTCAE 5.0, treatment-emergent adverse events (TEAEs), treatment related adverse events (TRAEs), and serious adverse events (SAEs) and the changes in vital signs, physical examination results, and laboratory test results before, during, and after the treatment. | 12-48 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |