ICIs With and Without MWA in Advanced Hepatocellular Carcinoma
NCT ID: NCT06581497
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2022-01-01
2026-01-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
19 Years
80 Years
ALL
No
Sponsors
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The First People's Hospital of Neijiang
OTHER
Responsible Party
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Ou Jiang
Director of Cancer Center
Locations
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The Second People's Hospital of Neijiang City
Neijiang, Sichuan, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2026RP-0106-03
Identifier Type: -
Identifier Source: org_study_id
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