Hepatocellular CarcinomaNCT07368023
A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma Non-resectable, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial summary
This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Locoregional Therapy (LRT) + Systemic Drug Therapy
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2026to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This retrospective single-center cohort study includes 300 HCC patients (2018-2024), divided by initial resectability: Initially Unresectable HCC Cohort（N=100）: Received multimodal conversion therapy (LRT + anti-VEGF/TKIs + ICIs) aiming to downstage tumors for resection. Initially Resectable HCC Cohort（N=200）: Underwent direct radical resection without prior conversion therapy. Patients were aged ≥16 with CNLC stage I-IIIA HCC. Exclusions: extrahepatic metastasis or Cheng's type IV PVTT/type II-III IVCTT. Data are collected retrospectively from EMR and an HCC database.
Who may be able to join
- Aged 16 years or older.
- Clinical and/or pathological diagnosis of hepatocellular carcinoma (HCC). China Liver Cancer (CNLC) stage I, II, or IIIA.
- Assessed by a multidisciplinary team (MDT) as having initially unresectable HCC.
Who cannot join
- Presence of extrahepatic metastasis.
- Presence of Cheng's type IV portal vein tumor thrombus (PVTT).
- Presence of Cheng's type II or III inferior vena cava tumor thrombus (IVCTT).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received multidisciplinary conversion therapy. This therapy combines locoregional treatments (LRT, such as TACE or radiotherapy) with systemic therapy (anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors) with the goal of down-staging tumors to allow for subsequent curative resection.
The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients with initially unresectable HCC who received the combined conversion therapy between January 2018 and December 2024. A control group of about 200 patients with initially resectable HCC who underwent direct radical surgery during the same period will be used for comparison. Data will be collected retrospectively from hospital electronic medical records and the HCC clinical database, with follow-up until December 2025.
- Being tested
- Locoregional Therapy (LRT) + Systemic Drug Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locoregional Therapy (LRT) + Systemic Drug TherapyCombination product
Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.
| Study group | Role | What they receive |
|---|---|---|
| Initially Unresectable HCC with Conversion Therapy | This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as unresectable (due to surgical inoperability or oncological unresectability per multidisciplinary team evaluation) but intended for curative treatment. All patients in this cohort received multimodal conversion therapy between January 2018 and December 2024. The therapy aimed to downstage the tumor and primarily included a combination of locoregional therapies (LRT) (such as TACE, HAIC, or radiotherapy) and systemic drug therapy (including anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors). Patient data are collected retrospectively from electronic medical records and the HCC clinical database. Receives: Combination Product: Locoregional Therapy (LRT) + Systemic Drug Therapy | |
| Initially Resectable HCC | This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as resectable and suitable for curative surgery per multidisciplinary team evaluation. All patients in this cohort underwent direct radical resection (curative-intent surgery) as the primary treatment between January 2018 and December 2024, without receiving prior locoregional or systemic conversion therapy. Patient data are collected retrospectively from electronic medical records and the HCC clinical database. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion Rate
Proportion of ITT patients with initially unresectable HCC successfully down-staged to resectability after conversion therapy (per MDT reassessment).
Measured: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).
1-, 2-, and 3-year OS in ITT Population
Proportion of patients in the ITT population alive at 1, 2, and 3 years after initiation of conversion therapy (Kaplan-Meier method).
Measured: Starting from conversion therapy, evaluate at 1, 2, and 3 years.
Resection Rate After Conversion
Proportion of patients who successfully undergo curative resection after down-staging.
Measured: From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start25 Jan 2026 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Caide Lu, Ningbo Medical Center Lihuili Hospital
- Investigators
- Caide Lu, Professor, Principal investigator, Ningbo Medical Centre Lihuili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368023
- Sponsor's protocol ID
- KY2025PJ484
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of individual participant data (IPD) has not yet been made. The research team is currently assessing the feasibility, institutional policies, and ethical considerations related to data de-identification and sharing. A final plan will be determined prior to the completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07368023
- Acronym / sponsor ID
- KY2025PJ484
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined conversion therapy strategy for patients with initially unresectable hepatocellular carcinoma (HCC).The primary objective is to assess the outcomes of intention-to-treat (ITT) patients who received multidisciplinary conversion therapy. This therapy combines locoregional treatments (LRT, such as TACE or radiotherapy) with systemic therapy (anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors) with the goal of down-staging tumors to allow for subsequent curative resection.
The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients with initially unresectable HCC who received the combined conversion therapy between January 2018 and December 2024. A control group of about 200 patients with initially resectable HCC who underwent direct radical surgery during the same period will be used for comparison. Data will be collected retrospectively from hospital electronic medical records and the HCC clinical database, with follow-up until December 2025.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initially Unresectable HCC with Conversion Therapy | – | Combination Product: Locoregional Therapy (LRT) + Systemic Drug TherapyThis cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as unresectable (due to surgical inoperability or oncological unresectability per multidisciplinary team evaluation) but intended for curative treatment. All patients in this cohort received multimodal conversion therapy between January 2018 and December 2024. The therapy aimed to downstage the tumor and primarily included a combination of locoregional therapies (LRT) (such as TACE, HAIC, or radiotherapy) and systemic drug therapy (including anti-VEGF/tyrosine kinase inhibitors and immune checkpoint inhibitors). Patient data are collected retrospectively from electronic medical records and the HCC clinical database. |
| Initially Resectable HCC | – | –This cohort consists of patients with hepatocellular carcinoma (HCC) that was initially assessed as resectable and suitable for curative surgery per multidisciplinary team evaluation. All patients in this cohort underwent direct radical resection (curative-intent surgery) as the primary treatment between January 2018 and December 2024, without receiving prior locoregional or systemic conversion therapy. Patient data are collected retrospectively from electronic medical records and the HCC clinical database. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This retrospective single-center cohort study includes 300 HCC patients (2018-2024), divided by initial resectability: Initially Unresectable HCC Cohort（N=100）: Received multimodal conversion therapy (LRT + anti-VEGF/TKIs + ICIs) aiming to downstage tumors for resection. Initially Resectable HCC Cohort（N=200）: Underwent direct radical resection without prior conversion therapy. Patients were aged ≥16 with CNLC stage I-IIIA HCC. Exclusions: extrahepatic metastasis or Cheng's type IV PVTT/type II-III IVCTT. Data are collected retrospectively from EMR and an HCC database.
Key inclusion criteria (3 listed)
- Aged 16 years or older.
- Clinical and/or pathological diagnosis of hepatocellular carcinoma (HCC). China Liver Cancer (CNLC) stage I, II, or IIIA.
- Assessed by a multidisciplinary team (MDT) as having initially unresectable HCC.
Key exclusion criteria (3 listed)
- Presence of extrahepatic metastasis.
- Presence of Cheng's type IV portal vein tumor thrombus (PVTT).
- Presence of Cheng's type II or III inferior vena cava tumor thrombus (IVCTT).
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 |
|---|---|---|
| Locoregional Therapy (LRT) + Systemic Drug TherapyTreatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively. | Combination product | Initially Unresectable HCC with Conversion Therapy |
Primary outcome
Conversion Rate
Time frame: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).
Proportion of ITT patients with initially unresectable HCC successfully down-staged to resectability after conversion therapy (per MDT reassessment).
1-, 2-, and 3-year OS in ITT Population
Time frame: Starting from conversion therapy, evaluate at 1, 2, and 3 years.
Proportion of patients in the ITT population alive at 1, 2, and 3 years after initiation of conversion therapy (Kaplan-Meier method).
Resection Rate After Conversion
Time frame: From the start of conversion therapy to the day of surgery (with a maximum evaluation period of 24 months).
Proportion of patients who successfully undergo curative resection after down-staging.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of individual participant data (IPD) has not yet been made. The research team is currently assessing the feasibility, institutional policies, and ethical considerations related to data de-identification and sharing. A final plan will be determined prior to the completion of the study
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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.
Caide Lu, Professor principal investigator
Ningbo Medical Centre Lihuili Hospital
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 Hepatocellular Carcinoma and Hepatocellular Carcinoma Non-resectable, run by Ningbo Medical Center Lihuili Hospital 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caide Lu, Professor (+8613957800900, lucaide@nbu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion Rate (time frame: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.