HCCIMI-aHCCNCT06581497

ICIs With and Without MWA in Advanced Hepatocellular Carcinoma

An observational study of HCC and Therapy Adverse Effect, run by The First People's Hospital of Neijiang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 19 to 80 years
Conditions the study is for: HCC, Therapy Adverse Effect
What is being tested?: ICIs and ICIs+MWA
Type of treatment: Surgery or procedure
How many people: 52 participants
Where: 1 siteChina
Study dates: 1 Jan 2022to 1 Jan 2026
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

The Second People's Hospital of Neijiang City
Neijiang, Sichuan, 641000

Other trials in China

About this study

Official title: Comparing the Efficacy of ICIs With and Without MWA in Advanced Hepatocellular Carcinoma in Real-World Clinical Practice

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.

Read the 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.

Conditions: HCC, Therapy Adverse Effect
Being tested: ICIs, ICIs+MWA
Keywords: HCC, anti-PD-1 mAbs, thermal ablation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ICIsDrug
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+MWAProcedure or surgery
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.

Study groups in NCT06581497
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: ICIs+MWA

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death from any cause.
Measured: 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.
Measured: 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)
According to the mRECIST criteria, the proportion of patients who achieve complete response (CR) or partial response (PR).
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20221 Jan 2026

First posted3 Sep 2024
Study start1 Jan 2022
Primary completion1 Jan 2026
Study completion1 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for HCCStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06581497
Sponsor's protocol ID: 2026RP-0106-03
Acronym: IMI-aHCC
Status last verified: Jan 2026
First submitted: 30 Aug 2024
Last updated: 14 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27312032
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.
PubMed 26980827
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.
PubMed 29516957
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.
PubMed 28635405
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.
PubMed 34344612
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.
PubMed 30927283
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.
PubMed 27585790
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.
PubMed 19828011
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.
PubMed 20532778
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.
PubMed 33565506
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.
PubMed 42137460

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HCC trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing the Efficacy of ICIs With and Without MWA in Advanced Hepatocellular Carcinoma in Real-World Clinical Practice
ClinicalTrials.gov ID: NCT06581497
Acronym / sponsor ID: IMI-aHCC / 2026RP-0106-03
Conditions: HCC, Therapy Adverse Effect
Keywords: HCC, anti-PD-1 mAbs, thermal ablation
Study type: Observational
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: The First People's Hospital of NeijiangUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 1 Jan 2026 (actual)
Study completion: 1 Jan 2026 (actual)
First posted: 3 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
ICIs	–	Drug: ICIsICIs 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	–	Procedure: ICIs+MWAICIs 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.

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ICIsICIs 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
ICIs+MWAICIs 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 or surgery	MWA+ICIs

Primary outcome

Progression-Free Survival (PFS)
Time frame: 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)
Time frame: 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.

1 secondary outcome

objective response rate (ORR)
Time frame: 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
Background: PubMed 27312032Grandhi 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.
Background: PubMed 26980827McGuire 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.
Background: PubMed 29516957Zhou 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.
Background: PubMed 28635405Zhang 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.
Background: PubMed 34344612Khan 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.
Background: PubMed 30927283Brown 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.
Background: PubMed 27585790van 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.
Background: PubMed 19828011Fatourou 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.
Background: PubMed 20532778Rao 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.
Background: PubMed 33565506Huang 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.
Derived from this study: PubMed 42137460Wei 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HCC and Therapy Adverse Effect, run by The First People's Hospital of Neijiang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06581497, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.