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This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group LS | Logical therapy combined with systemic therapy |
| |
| Group S | Systemic therapy alone(PD-1/PD-L1 inhibits and anti-angiogenic agents) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TACE/HAIC | Procedure | TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment; |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | The time from the beginning of treatment to the time of tumor progression or death from any cause (according to mRECIST and RECIST v1.1) | Up to 48 months |
| ORR | The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1 | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| OS | OS was defined as the interval from the date of the initial administration of any drug/procedure to death from any cause. | Up to 48 months |
| Safety | Safety was defined the incidence and severity of adverse events (AEs) and serious adverse events (SAEs). The severity of AEs were evaluated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI-CTCAE) v5.0. |
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Inclusion Criteria:
Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically.
Patients with Barcelona (BCLC) stage B and C beyond up to seven;
Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy);
Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications);
*The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week
TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;
TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE;
There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria
Exclusion Criteria:
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Patients with intermediate and advanced hepatocellular carcinoma beyond up to seven
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lan Zhang, MD, Ph.D | Contact | 13918876432 | zhang.lan@zs-hospital.sh.cn |
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| PD-1/PD-L1 inhibits and anti-angiogenic agents | Drug | Agents were administrated based on the instructions recommended |
|
| Up to 48 months |
| 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 |
|---|---|
| D020533 | Angiogenesis Inhibitors |
| ID | Term |
|---|---|
| D043924 | Angiogenesis Modulating Agents |
| D006133 | Growth Substances |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D006131 | Growth Inhibitors |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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