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The goal of this clinical trial is to evaluate whether sequential transarterial chemoembolization (TACE) followed by stereotactic body radiotherapy (SBRT) combined with targeted immunotherapy is effective and safe for patients with intermediate to advanced hepatocellular carcinoma (HCC) who are not eligible for curative treatment such as surgery or liver transplantation.
This is a single-center, single-arm, retrospective study. All participants included in the analysis will have received the combined treatment regimen.
The main question the study aims to answer is:
Can sequential TACE-SBRT combined with targeted immunotherapy improve the objective response rate (ORR) in patients with intermediate to advanced HCC?
Interventions
Participants in this study have undergone the following treatments:
TACE: a minimally invasive procedure to block the blood supply to the tumor while delivering chemotherapy directly.
SBRT: a highly precise form of radiation therapy targeting the liver tumor. Targeted immunotherapy: systemic treatment that stimulates the immune system to recognize and attack cancer cells.
Participant Population The study includes adult patients diagnosed with intermediate to advanced HCC who were not candidates for curative resection or transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential TACE-SBRT With Targeted Immunotherapy Group |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) according to mRECIST | Objective response rate (complete response + partial response) assessed by mRECIST based on imaging evaluation. | At baseline and every 3 months after treatment initiation, up to study completion (an average of 6months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From treatment initiation until death from any cause, up to study completion (an average of 26 months) | |
| Progression-Free Survival (PFS) according to mRECIST | Time from treatment initiation to disease progression or death, assessed by mRECIST. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with intermediate to advanced hepatocellular carcinoma (HCC) who received sequential TACE-SBRT followed by targeted immunotherapy at a single tertiary medical center. Eligible participants were adults (≥18 years) with unresectable disease not suitable for curative surgery or liver transplantation, with preserved liver function and measurable lesions. The population represents a hospital-based cohort identified from medical records rather than a community sample.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hosptial | Guangzhou | 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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| From treatment initiation until disease progression or death, whichever occurs first, up to study completion (an average of 15 months) |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | From treatment initiation through study completion, up to 18 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |