ICIs with and Without MWA in Advanced Hepatocellular Carcinoma
- Conditions
- HCCTherapy Adverse Effect
- Interventions
- Drug: ICIsProcedure: ICIs+MWA
- Registration Number
- NCT06581497
- Lead Sponsor
- The First People's Hospital of Neijiang
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 52
- Gender is not limited, age range is 19-80 years old.
- Meets the clinical diagnostic criteria for HCC.
- Progress after first-line treatment.
- CNLC staging: Stage IIa, IIb, or IIIb of advanced HCC.
- Child Pugh liver function grading score 5-7 points.
- The ECOG (Eastern Cooperative Oncology Group) score ranges from 0 to 1.
- The patient has a certain degree of compliance with the treatment plan and follow-up performance.
- For patients infected with hepatitis B, antiviral treatment with anti hepatitis B virus drugs should be carried out before receiving treatment; And the hepatitis B DNA titer of the patient was less than 10^2 IU/ml.
- It has been determined that the inclusion criteria cannot be met.
- Enhanced CT or MRI shows more than 3 active lesions in the liver, and the shortest diameter of a single lesion is greater than 3cm.
- There is a portal vein cancer thrombus present.
- The extrahepatic metastatic lesions have not been well controlled.
- Other treatments were received during the process of receiving immunotherapy or immunotherapy combined with MWA treatment.
- There is active bleeding present.
- There are interstitial lung diseases, pulmonary fibrosis, and autoimmune diseases present.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICIs 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. MWA+ICIs 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.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Progression-Free Survival was assessed from the date of treatment initiation until the date of first documented disease progression or death from any cause, whichever occurred first, assessed up to 24 months. Time from treatment initiation to disease progression or death from any cause.
Overall Survival (OS) Overall Survival was measured from the date of treatment initiation until death from any cause or patients who were still alive at the last follow-up were censored at that time point, assessed up to 36 months. Time from treatment initiation to disease progression or death from any cause.
- Secondary Outcome Measures
Name Time Method objective response rate (ORR) Objective response rate was measured from baseline to 24 months, every 8 weeks or until disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurs first. According to the mRECIST criteria, the proportion of patients who achieve complete response (CR) or partial response (PR).
Trial Locations
- Locations (1)
The First People's Hospital of Neijiang City
🇨🇳Neijiang, Sichuan, China