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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420922
• Other study ID #: CHL2022
• Status: Recruiting
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Tongji Hospital
• Contact: Changhai Li, Doctor
• Phone: 8613986231269
• Email: tjlichanghai[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lenvatinib Oral Product
Lenvatinib or Sorafenib
• PD-1 inhibitor
Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1

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

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective response rate (ORR)	ORR in three groups were compared	8 weeks
Primary	The overall survival (OS)	1 year OS in three groups were compared	12 months
Primary	The treatment-related adverse events (TRAEs)	Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0	12 months
Secondary	The progression-free survival (PFS)	ORR in three groups were compared	8 weeks