Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Immune Checkpoint Inhibitors (ICIs) and Tyrosine Kinase Inhibitors (TKIs) Therapy for Hepatocellular Carcinoma (HCC)：a Multicenter, Retrospective Study on the Real-world in China

Conditions
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Effects of Immunotherapy, Hepatocellular Carcinoma, Programmed Cell Death 1

Intervention / Treatment
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* Drug: Lenvatinib Oral Product
* Drug: PD-1 inhibitor
* Procedure: Local treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of hepatocellular carcinoma Treated with ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib) Treated with local therapy (TACE, HAIC, RF ablation, microwave ablation, radiotherapy, etc) Treated Treated with ICIs plus TKIs and local therapy Have complete medical record that can complete the OR or 1 year OS assessment and follow-up. Exclusion Criteria: Patients who do not have complete medical record and follow-up information after treatment； The researchers have evidence that it is not suitable for this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Systemic therapy<br>ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) | Drug: Lenvatinib Oral Product<br>* Lenvatinib or Sorafenib<br>Drug: PD-1 inhibitor<br>* Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1<br>|
| Local treatment<br>local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc. | Procedure: Local treatment<br>* Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.<br>|
| Triple therapy<br>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) | Drug: Lenvatinib Oral Product<br>* Lenvatinib or Sorafenib<br>Drug: PD-1 inhibitor<br>* Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1<br>Procedure: Local treatment<br>* Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The progression-free survival (PFS) | ORR in three groups were compared | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lenvatinib, Sorafenib, Programmed Cell Death 1, Real-world study, transcatheter arterial chemoembolization