Clinical trial NCT05420922: Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Programmed Cell Death 1
Effects of Immunotherapy
Keywords: Lenvatinib
Sorafenib
Programmed Cell Death 1
Real-world study
transcatheter arterial chemoembolization
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatocellular carcinoma patients using ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib), ICIs plus TKIs with local therapy (TACE, HAIC, RF ablation, microwave ablation, etc), local therapy only

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.

Eligibility criteria: 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

Primary outcomes:
measure: The objective response rate (ORR)
timeFrame: 8 weeks
measure: The overall survival (OS)
timeFrame: 12 months
measure: The treatment-related adverse events (TRAEs)
timeFrame: 12 months
Secondary outcomes:
measure: The progression-free survival (PFS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Xiaoping Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: