NCT06818097

Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC

Efficacy Analysis of the Combined Target - Immunotherapy and XELOX Chemotherapy Regimen in the Treatment of Advanced Hepatocellular Carcinoma.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In China, primary hepatocellular carcinoma (HCC) has high morbidity and mortality, imposing a heavy burden on the public. Surgical resection is an effective treatment, but as HCC is often latent, less than 30% of patients are suitable for surgery at first diagnosis. So systemic anti-tumor therapy is crucial for advanced HCC. Small-molecule targeted drugs like lenvatinib and sorafenib are NCCN-recommended first-line drugs for advanced HCC. The combination of targeted drugs and immune checkpoint inhibitors can prolong overall survival with good safety. The "2024 Guidelines for HCC Diagnosis and Treatment" shows that platinum-containing chemotherapy is a preferred systemic treatment for advanced HCC. However, in real-world practice, the efficacy and safety of the combination of targeted-immunotherapy and chemotherapy regimen for advanced HCC remain unclear.

Detailed description

This study is a retrospective cohort study aimed at evaluating the efficacy and safety of TKI + PD-1 inhibitor + XELOX chemotherapy in the treatment of advanced HCC. The study included the clinical data of 68 patients with advanced HCC who could not undergo radical surgical resection and received first-line triple-drug therapy (lenvatinib as TKI + camrelizumab/ tislelizumab/ atezolizumab as PD-1 inhibitor + capecitabine and oxaliplatin as XELOX chemotherapy regimen) in the Hepatobiliary Surgery Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University from April 2022 to December 2024. Demographic information, imaging information, blood biochemistry, blood routine, alpha - fetoprotein and other information of patients were collected as baseline information. Subsequently, based on the RECIST v1.1 standard, the objective response rate (ORR) evaluated by the researchers was set as the primary endpoint, and the surgical conversion rate, overall survival (OS), progression - free survival (PFS), and the incidence of adverse events were analyzed as secondary endpoints.

Conditions

• Advanced HCC
• Systemic Therapy
• Chemotherapy
• Immunotherapy
• Targeted Therapy
• Efficacy and Safety

Interventions

Type	Name	Description
DRUG	TKI	Lenvatinib
DRUG	anti PD-1	Sintilimab or Camrelizumab or Tislelizumab
DRUG	XELOX chemotherapy	Capecitabine and Oxaliplatin

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2025-02-10
• Last updated: 2025-05-20

Locations

1 site across 1 country: China