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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICIs | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Time from treatment initiation to disease progression or death from any cause. | 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. |
| Overall Survival (OS) | Time from treatment initiation to disease progression or death from any cause. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | According to the mRECIST criteria, the proportion of patients who achieve complete response (CR) or partial response (PR). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second People's Hospital of Neijiang City | Neijiang | Sichuan | 641000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27312032 | Background | Grandhi MS, Kim AK, Ronnekleiv-Kelly SM, Kamel IR, Ghasebeh MA, Pawlik TM. Hepatocellular carcinoma: From diagnosis to treatment. Surg Oncol. 2016 Jun;25(2):74-85. doi: 10.1016/j.suronc.2016.03.002. Epub 2016 Mar 5. | |
| 26980827 | Background | McGuire S. World Cancer Report 2014. Geneva, Switzerland: World Health Organization, International Agency for Research on Cancer, WHO Press, 2015. Adv Nutr. 2016 Mar 15;7(2):418-9. doi: 10.3945/an.116.012211. Print 2016 Mar. No abstract available. |
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| ICIs+MWA | Procedure | 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. |
|
| 29516957 | Background | Zhou Y, Xu X, Ding J, Jing X, Wang F, Wang Y, Wang P. Dynamic changes of T-cell subsets and their relation with tumor recurrence after microwave ablation in patients with hepatocellular carcinoma. J Cancer Res Ther. 2018 Jan;14(1):40-45. doi: 10.4103/jcrt.JCRT_775_17. |
| 28635405 | Background | Zhang H, Hou X, Cai H, Zhuang X. Effects of microwave ablation on T-cell subsets and cytokines of patients with hepatocellular carcinoma. Minim Invasive Ther Allied Technol. 2017 Aug;26(4):207-211. doi: 10.1080/13645706.2017.1286356. Epub 2017 Feb 20. |
| 34344612 | Background | Khan AA, Liu ZK, Xu X. Recent advances in immunotherapy for hepatocellular carcinoma. Hepatobiliary Pancreat Dis Int. 2021 Dec;20(6):511-520. doi: 10.1016/j.hbpd.2021.06.010. Epub 2021 Jul 24. |
| 30927283 | Background | Brown ZJ, Greten TF, Heinrich B. Adjuvant Treatment of Hepatocellular Carcinoma: Prospect of Immunotherapy. Hepatology. 2019 Oct;70(4):1437-1442. doi: 10.1002/hep.30633. Epub 2019 Sep 19. |
| 27585790 | Background | van den Bijgaart RJ, Eikelenboom DC, Hoogenboom M, Futterer JJ, den Brok MH, Adema GJ. Thermal and mechanical high-intensity focused ultrasound: perspectives on tumor ablation, immune effects and combination strategies. Cancer Immunol Immunother. 2017 Feb;66(2):247-258. doi: 10.1007/s00262-016-1891-9. Epub 2016 Sep 1. |
| 19828011 | Background | Fatourou EM, Koskinas JS. Adaptive immunity in hepatocellular carcinoma: prognostic and therapeutic implications. Expert Rev Anticancer Ther. 2009 Oct;9(10):1499-510. doi: 10.1586/era.09.103. |
| 20532778 | Background | Rao P, Escudier B, de Baere T. Spontaneous regression of multiple pulmonary metastases after radiofrequency ablation of a single metastasis. Cardiovasc Intervent Radiol. 2011 Apr;34(2):424-30. doi: 10.1007/s00270-010-9896-9. Epub 2010 Jun 8. |
| 33565506 | Background | Huang ZM, Lai CX, Zuo MX, An C, Wang XC, Huang JH, Ning E. Adjuvant cytokine-induced killer cells with minimally invasive therapies augmented therapeutic efficacy of unresectable hepatocellular carcinoma. J Cancer Res Ther. 2020;16(7):1603-1610. doi: 10.4103/jcrt.JCRT_962_19. |
| 42137460 | Derived | Wei C, Chen S, Ding L, Zhou T, Huang F, Wang Y, Jiang O, Liu Y. Comparing the efficacy of immune checkpoint inhibitors with and without microwave ablation in advanced hepatocellular carcinoma in real-world clinical practice: A retrospective cohort study. Oncol Lett. 2026 May 4;32(1):278. doi: 10.3892/ol.2026.15633. eCollection 2026 Jul. |