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

Tongji Hospital

Status: Enrolling

Conditions: Effects of Immunotherapy; Hepatocellular Carcinoma; Programmed Cell Death 1

Treatments: Drug: PD-1 inhibitor; Procedure: Local treatment; Drug: Lenvatinib Oral Product

Study type: Observational

Funder types: Other

Identifiers

NCT05420922

CHL2022

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 3 patient groups

Systemic therapy

Description:

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

Treatment:

Drug: PD-1 inhibitor

Drug: Lenvatinib Oral Product

Local treatment

Description:

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

Treatment:

Procedure: Local treatment

Triple therapy

Description:

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)

Treatment:

Drug: PD-1 inhibitor

Procedure: Local treatment

Drug: Lenvatinib Oral Product