ICIs With and Without MWA in Advanced Hepatocellular Carcinoma

NCT06581497 | Completed DMC

• 1 other identifier: 2026RP-0106-03
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

HCC; Therapy Adverse Effect

Keywords

HCC; anti-PD-1 mAbs; thermal ablation

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

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.

Drug: ICIs

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.

Procedure: ICIs+MWA

Interventions

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.

ICIs

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.

MWA+ICIs

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Neijiang: lead

Study Sites (1)

The Second People's Hospital of Neijiang City

Neijiang, Sichuan, 641000, China

Location

Related Publications (10)

• 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.

  PMID: 27312032 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.

  PMID: 26980827 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.

  PMID: 29516957 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.

  PMID: 28635405 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.

  PMID: 34344612 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.

  PMID: 30927283 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.

  PMID: 27585790 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.

  PMID: 19828011 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.

  PMID: 20532778 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.

  PMID: 33565506 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cancer Center

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)