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| Name | Class |
|---|---|
| Zhujiang Hospital | OTHER |
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The goal of this observational study is to learn about the long-term treatment outcomes for patients with initially unresectable hepatocellular carcinoma (HCC) who achieve successful downstaging with the combination therapy of TACE, lenvatinib, and a PD-1 inhibitor. The main questions it aims to answer are:
Can distinct disease subtypes be identified in successfully downstaged patients using radiomics and clinical data?
Do these different subtypes show significant differences in long-term outcomes, such as recurrence-free survival and overall survival, after undergoing either curative-intent surgical resection or continuing maintenance therapy?
Based on the identified subtypes, can the investigators objectively determine which patients are more suitable for surgical resection and which patients may benefit more from continued maintenance therapy after successful downstaging?
The study will include patients who have already undergone the combination therapy as part of their regular medical care, successfully achieved tumor downstaging (making the tumor technically resectable), and subsequently received either surgical resection or continued maintenance treatment. Researchers will retrospectively analyze their existing clinical and imaging data to compare long-term outcomes between these two treatment paths based on their identified disease subtype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance group | This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after successful downstaging achieved through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, continued with the same non-surgical, maintenance treatment regimen instead of undergoing surgical resection. |
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| Liver Resection group | This group consists of patients with initially unresectable hepatocellular carcinoma (HCC) who, after achieving successful downstaging through the combination therapy of Transarterial Chemoembolization (TACE), lenvatinib, and a PD-1 inhibitor, underwent curative-intent surgical resection (R0 resection) as their subsequent treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver resection | Procedure | This intervention consists of curative-intent surgical resection of hepatocellular carcinoma (HCC) performed after successful downstaging achieved through prior TACE combined with lenvatinib and PD-1 inhibitor therapy. The procedure aims to remove all visible and radiologically responsive tumor tissue to achieve a pathologically confirmed R0 resection margin. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival | Time interval from date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months | From date of initial treatment until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time interval from date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months | From date of initial treatment until the date of death from any cause, whichever came first, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with initially unresectable hepatocellular carcinoma who were treated with a combination therapy of TACE, lenvatinib, and a PD-1 inhibitor and subsequently achieved successful tumor downstaging.
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| Name | Affiliation | Role |
|---|---|---|
| Wenzhe Fan, Dr. | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Shunjun Fu, Dr. | Southern Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiiated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China | ||
| Zhujiang Hospital of Southern Medical University |
The dataset contains detailed and potentially re-identifiable patient information, including medical images, clinical records, and treatment outcomes. Due to institutional data privacy policies, ethical restrictions related to patient confidentiality, and the lack of broad consent from participants for data sharing beyond the scope of this specific research, the investigators are unable to publicly share individual participant data (IPD). All data will be stored securely within the hospital's internal research database, and access will be restricted to the study investigators for analysis purposes only. Requests for aggregated or de-identified results may be considered upon reasonable inquiry to the corresponding author, subject to institutional review and compliance with applicable regulations.
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| TACE plus Lenvatinib and PD1 inhibiter | Procedure | This intervention describes the non-surgical maintenance therapy for patients in the Maintenance Group after successful downstaging. It consists of continuing the same doses of lenvatinib and PD-1 inhibitor that were administered during the downstaging phase, combined with on-demand TACE performed only upon imaging or biomarker evidence of intrahepatic progression. |
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| Guangzhou |
| Guangdong |
| 510280 |
| China |
| 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 |
|---|---|
| D006498 | Hepatectomy |
| C531958 | lenvatinib |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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