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China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.
This was a multi-center, retrospective study involving 2000 patients with HCC receiving ICIs (Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1)) and TKIs (Lenvatinib or Sorafenib), ICIs and TKIs plus local treatment (TAC, Hepatic artery infusion chemotherapy (HAIC), radiofrequency (RF) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between Jan, 2019 and Dec, 2021 in China. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and 1year and 2 years overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of three groups were compared. Stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic therapy | ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) |
| |
| Local treatment | local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc. |
| |
| Triple therapy | Systemic therapy plus Local treatment: ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenvatinib Oral Product | Drug | Lenvatinib or Sorafenib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The objective response rate (ORR) | ORR in three groups were compared | 8 weeks |
| The overall survival (OS) | 1 year OS in three groups were compared | 12 months |
| The treatment-related adverse events (TRAEs) | Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The progression-free survival (PFS) | ORR in three groups were compared | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Hepatocellular carcinoma patients using ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib), ICIs plus TKIs with local therapy (TACE, HAIC, RF ablation, microwave ablation, etc), local therapy only
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changhai Li, Doctor | Contact | 8613986231269 | tjlichanghai@126.com | |
| Xiaoping Chen | Contact | +862783663400 | chenxp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoping Chen, Doctor | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
We haven't decided whether it needs to cooperate with other PI.
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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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| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| PD-1 inhibitor |
| Drug |
Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1 |
|
| Local treatment | Procedure | Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc. |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |