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

• Conditions: Hepatocellular Carcinoma; Programmed Cell Death 1; Effects of Immunotherapy
• Interventions: Drug: Lenvatinib Oral Product; Procedure: Local treatment; Drug: PD-1 inhibitor

• Registration Number: NCT05420922
• Lead Sponsor: Tongji Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-05-26
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-11
• Last Update Submitted: 2022-06-11
• Study First Posted: 2022-06-15
• Last Update Posted: 2022-06-15
• Primary Completion: 2022-08-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Systemic therapy	Lenvatinib Oral Product	ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)
Systemic therapy	PD-1 inhibitor	ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)
Local treatment	Local treatment	local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.
Triple therapy	Lenvatinib Oral Product	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)
Triple therapy	PD-1 inhibitor	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)
Triple therapy	Local treatment	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)

Primary Outcome Measures

Name	Time	Method
The overall survival (OS)	12 months	1 year OS in three groups were compared
The treatment-related adverse events (TRAEs)	12 months	Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0
The objective response rate (ORR)	8 weeks	ORR in three groups were compared

Secondary Outcome Measures

Name	Time	Method
The progression-free survival (PFS)	8 weeks	ORR in three groups were compared

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China