NCT06581497

ICIs With and Without MWA in Advanced Hepatocellular Carcinoma

Comparing the Efficacy of ICIs With and Without MWA in Advanced Hepatocellular Carcinoma in Real-World Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: The First People's Hospital of Neijiang · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy has become the main treatment recommendation for HCC. MWA treatment induces peripheral immune response, which may enhance the effectiveness of immunotherapy for advanced HCC. This study aims to compare the efficacy and safety of ICIs combined with MWA compared to ICIs alone. The study will compare two groups: ICIs and ICIs+MWA. Main objectives: OS, PFS Secondary objectives: CR PR、SD、PD、ORR、DCR、AEs This study addresses the efficacy and safety of using ICIs in combination with MWA compared to ICIs alone for advanced HCC patients. The investigators' study aims to evaluate the necessity of immunotherapy combined with targeted drugs or microwave ablation in patients with advanced hepatocellular carcinoma in the real world, providing relevant clinical data for the treatment selection of HCC patients.

Detailed description

Research Title: Comparing the Efficacy of ICIs with and without MWA in Advanced Hepatocellular Carcinoma in Real Clinical Practice Background: Immunotherapy has become the main treatment recommendation for cancer. Ablation therapy induces peripheral immune response, which may enhance the effectiveness of immunotherapy in patients with advanced hepatocellular carcinoma (HCC). Main objectives: OS, PFS Secondary objectives: CR PR、SD、PD、ORR、DCR、AEs Research Design: This is a single center, retrospective cohort study. This study addresses the efficacy and safety of using ICIs in combination with MWA compared to ICIs alone for advanced HCC patients. Meaning: The investigators' study aims to evaluate the necessity of immunotherapy combined with targeted drugs or microwave ablation in patients with advanced hepatocellular carcinoma in the real world, providing relevant clinical data for the treatment selection of HCC patients. Innovation: The innovation of this paper lies in the first verification of the efficacy and safety of microwave ablation (MWA) combined with immune checkpoint inhibitors (ICIs) in the treatment of advanced hepatocellular carcinoma (HCC) patients. Expected results: The innovation of this paper lies in the first validation of the significant efficacy of microwave ablation (MWA) combined with immune checkpoint inhibitors (ICIs) in the treatment of advanced hepatocellular carcinoma (HCC) patients, significantly improving overall survival (OS) and progression free survival (PFS), as well as objective response rate (ORR) and disease control rate (DCR). Conclusion: The investigators' study aims to evaluate the necessity of immunotherapy combined with targeted drugs or microwave ablation in patients with advanced hepatocellular carcinoma in the real world, providing relevant clinical data for the treatment selection of HCC patients.

Conditions

• HCC
• Therapy Adverse Effect

Interventions

Type	Name	Description
DRUG	ICIs	ICIs mainly refer to PD-1 drug therapy, including pembrolizumab, camrizumab, toripalimab, tislelizumab, and sintilimab. The dosage and duration of ICIs comply with the manufacturer's guidelines.
PROCEDURE	ICIs+MWA	ICIs mainly refer to PD-1 drug therapy, including pembrolizumab, camrizumab, toripalimab, tislelizumab, and sintilimab. The dosage and duration of ICIs comply with the manufacturer's guidelines. All patients, except for those enrolled in ICIs, should also undergo MWA treatment.

Timeline

• Start date: 2022-01-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-09-03
• Last updated: 2026-01-14

Locations

1 site across 1 country: China