Clinical trial NCT06581497: ICIs with and Without MWA in Advanced Hepatocellular Carcinoma
Official title: Comparing the Efficacy of ICIs with and Without MWA in Advanced Hepatocellular Carcinoma in Real-World Clinical Practice
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HCC
Therapy Adverse Effect
Keywords: HCC
anti-PD-1 mAbs
thermal ablation
Lead sponsor: The First People's Hospital of Neijiang
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators applied inclusion criteria, requiring a score of 0-1 for the Eastern Cooperative Oncology Group Performance Status (ECOG PS), The study includes patients in BCLC phases B and C, classified as Child Pugh A or B (score ≤ 7 points), with an expected lifespan of at least 3 months. Other inclusion criteria are liver function ≤ twice the upper limit of the normal value, creatinine ≤ 1.5 times the upper limit of the normal value, serum albumin level \> 25 g/L, platelet count \> 50 × 10\^9/mm³, precursor activity \> 50%, total white blood cell count \> 1.5 × 10\^9/mm³, and hemoglobin level \> 80 g/m³. Primary exclusion criteria include interstitial lung disease, pulmonary fibrosis, autoimmune disease, and a history of liver transplantation.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: 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.
Secondary outcomes:
measure: objective response rate (ORR)
timeFrame: 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.
Other outcomes:
Locations:
city: Neijiang
country: China
facility: The First People's Hospital of Neijiang City
state: Sichuan
Study officials:
References:
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