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This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received multidisciplinary conversion therapy. This therapy combines locoregional treatments (LRT, such as TACE or radiotherapy) with systemic therapy (anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors) with the goal of down-staging tumors to allow for subsequent curative resection.
The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients with initially unresectable HCC who received the combined conversion therapy between January 2018 and December 2024. A control group of about 200 patients with initially resectable HCC who underwent direct radical surgery during the same period will be used for comparison. Data will be collected retrospectively from hospital electronic medical records and the HCC clinical database, with follow-up until December 2025.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initially Unresectable HCC with Conversion Therapy | This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as unresectable (due to surgical inoperability or oncological unresectability per multidisciplinary team evaluation) but intended for curative treatment. All patients in this cohort received multimodal conversion therapy between January 2018 and December 2024. The therapy aimed to downstage the tumor and primarily included a combination of locoregional therapies (LRT) (such as TACE, HAIC, or radiotherapy) and systemic drug therapy (including anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors). Patient data are collected retrospectively from electronic medical records and the HCC clinical database. |
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| Initially Resectable HCC | This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as resectable and suitable for curative surgery per multidisciplinary team evaluation. All patients in this cohort underwent direct radical resection (curative-intent surgery) as the primary treatment between January 2018 and December 2024, without receiving prior locoregional or systemic conversion therapy. Patient data are collected retrospectively from electronic medical records and the HCC clinical database. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locoregional Therapy (LRT) + Systemic Drug Therapy | Combination Product | Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion Rate | Proportion of ITT patients with initially unresectable HCC successfully down-staged to resectability after conversion therapy (per MDT reassessment). | From the start of conversion therapy until the completion of therapy (assessed up to 24 months). |
| 1-, 2-, and 3-year OS in ITT Population | Proportion of patients in the ITT population alive at 1, 2, and 3 years after initiation of conversion therapy (Kaplan-Meier method). | Starting from conversion therapy, evaluate at 1, 2, and 3 years. |
| Resection Rate After Conversion | Proportion of patients who successfully undergo curative resection after down-staging. | From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months). |
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Inclusion Criteria:
Exclusion Criteria:
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This retrospective single-center cohort study includes 300 HCC patients (2018-2024), divided by initial resectability:
Initially Unresectable HCC Cohort（N=100）: Received multimodal conversion therapy (LRT + anti-VEGF/TKIs + ICIs) aiming to downstage tumors for resection.
Initially Resectable HCC Cohort（N=200）: Underwent direct radical resection without prior conversion therapy.
Patients were aged ≥16 with CNLC stage I-IIIA HCC. Exclusions: extrahepatic metastasis or Cheng's type IV PVTT/type II-III IVCTT. Data are collected retrospectively from EMR and an HCC database.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caide Lu, Professor | Contact | +8613957800900 | lucaide@nbu.edu.cn | |
| Shuqi Mao, Professor | Contact | +8617855848257 | mmmaoshuqi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Caide Lu, Professor | Ningbo Medical Centre Lihuili Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo Medical Centre Lihuili Hospital | Ningbo | Zhejiang | 315000 | China |
A decision regarding the sharing of individual participant data (IPD) has not yet been made. The research team is currently assessing the feasibility, institutional policies, and ethical considerations related to data de-identification and sharing. A final plan will be determined prior to the completion of the study
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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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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