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This is a prospective cohort study designed to evaluate the effectiveness and safety of two post-conversion treatment strategies for patients with initially unresectable hepatocellular carcinoma (uHCC). Participants first receive conversion therapy with transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After this therapy, patients who achieve complete radiological response (rCR) or meet resectability criteria will either undergo surgical resection or continue systemic therapy. The study aims to compare outcomes between these two strategies to help guide treatment decisions for advanced liver cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic Therapy Group | Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then continued systemic therapy. | ||
| Surgical Resection Group | Patients with initially unresectable hepatocellular carcinoma who achieved complete radiological response or resectability after TACE/HAIC + anti-angiogenic agents + immune checkpoint inhibitors and then underwent surgical resection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) | Defined as the time from the date of achieving rCR or resectability criteria to the time of becoming inoperable, recurrence, progression, or death from any cause for uHCC patients. | From initiation of post-conversion therapy to the first documented event (recurrence, progression, or death), up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 2-Year Event-Free Survival (EFS) Rate | Defined as the rate of no events (recurrence, progression, or death from any cause) occurring in rCR patients over 2 years. | 2 years after initiation of post-conversion therapy |
| Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are adults (18-75 years) with initially unresectable hepatocellular carcinoma (uHCC) diagnosed by histology/cytology or according to AASLD criteria and Chinese national guidelines. These patients have received conversion therapy consisting of transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After conversion therapy, participants have achieved radiological complete response (rCR) or reached resectability criteria and then either undergo curative liver resection or continue systemic therapy. Eligible patients must have Child-Pugh class A or B liver function and ECOG performance status 0-1.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ao Huang, PhD | Contact | +86-21-64041990 | huang.ao@zs-hospital.sh.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2025 |
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Defined as the survival time from the day of achieving rCR to death from any cause。
| Up to 36 months after initiation of post-conversion therapy |
| Treatment Safety | : The incidence of adverse events in the surgery group and the systemic therapy group. Adverse events recorded on the CRF will be mapped to preferred terms using the Medical Dictionary for Regulatory Activities (MedDRA). Severity, seriousness/grade, and the relationship with the study treatment will be assessed by the investigators. The seriousness/grade will be defined according to the National Cancer Institute (NCI) CTCAE v5.0. | From initiation of post-conversion therapy through 30 days after last treatment or surgery, up to 36 months follow-up |
| Cost-Effectiveness of Post-Conversion Treatment Strategies | The cost-effectiveness ratio (C/E) is defined as the ratio of time to an event (EFS) or overall survival (death) from rCR to all direct costs (medical expenses, including outpatient and inpatient), and will be compared between the two groups. | Up to 36 months after initiation of post-conversion therapy |
| Sep 25, 2025 |
| Prot_SAP_000.pdf |
| 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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