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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Hepatocellular Carcinoma Programmed Cell Death 1 Effects of Immunotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Systemic therapy

ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)

Lenvatinib Oral Product

Intervention Type DRUG

Lenvatinib or Sorafenib

PD-1 inhibitor

Intervention Type DRUG

Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1

Local treatment

local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Local treatment

Intervention Type PROCEDURE

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)

Lenvatinib Oral Product

Intervention Type DRUG

Lenvatinib or Sorafenib

PD-1 inhibitor

Intervention Type DRUG

Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1

Local treatment

Intervention Type PROCEDURE

Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Interventions

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Lenvatinib Oral Product

Lenvatinib or Sorafenib

Intervention Type DRUG

PD-1 inhibitor

Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1

Intervention Type DRUG

Local treatment

Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No