Hepatocellular CarcinomaNCT07310836
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 Hepatocellular Carcinoma Beyond UCSF Criteria Before Liver Transplantation
An observational study of Hepatocellular Carcinoma and Liver Transplantation, run by Ningbo Medical Center Lihuili Hospital.
Trial summary
This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined treatment strategy for patients with hepatocellular carcinoma (HCC) who are beyond the UCSF criteria but intended for liver transplantation. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Transplantation
- What is being tested?
- Locoregional Therapy (LRT) + Systemic Drug Therapy
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 31 Mar 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 plans to include 300 patients with HCC. All patients were managed at the study center between January 1, 2020, and December 31, 2024. 1. Beyond UCSF Criteria Cohort (n = 100): Patients with HCC tumors exceeding the UCSF transplant criteria but intended for liver transplantation. All patients in this cohort received multimodal conversion therapy, combining locoregional therapies with systemic therapy. 2. Within UCSF Criteria Cohort (n = 200): A control group of patients whose HCC tumors met the UCSF criteria at the time of listing and were directly registered for liver transplantation without receiving the aforementioned conversion therapy.
Who may be able to join
- Age ≥16;
- Clinical diagnosis of HCC;
- CNLC Stage I-IIIA.
Who cannot join
- Extrahepatic metastasis;
- Type IV portal vein tumor thrombus.
Trial locations and contacts
No sites are listed yet. 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 treatment strategy for patients with hepatocellular carcinoma (HCC) who are beyond the UCSF criteria but intended for liver transplantation. The primary objective is to assess the outcomes of these "intention-to-treat" patients who received locoregional therapies (LRT, such as TACE or radiotherapy) in combination with systemic therapy (anti-VEGF/Tyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors) as a "conversion therapy" prior to potential transplantation. This approach is distinct from traditional bridging or down-staging therapies by incorporating more aggressive systemic regimens. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients beyond UCSF criteria who received the combined conversion therapy between January 2020 and December 2024. A control group of about 200 patients who met the UCSF criteria and were directly listed for transplantation in the same period will be used for comparison. Data will be collected from medical records and the China Liver Transplant Registry (CLTR), with follow-up until December 2025.
Primary outcome measures include:
Read more
Objective Response Rate (ORR) of conversion therapy per mRECIST. Rate of successful down-staging to meet UCSF criteria.
1-, 2-, and 3-year overall survival (OS) rates of the intention-to-treat population.
Actual liver transplantation rate after successful conversion. Post-transplant 1-, 2-, and 3-year OS and recurrence-free survival (RFS) rates.
Secondary outcomes involve:
Safety profiles of both conversion therapy and subsequent transplantation. Analysis of factors influencing conversion success and treatment efficacy. Determination of an optimal washout period for Immune Checkpoint Inhibitors prior to transplantation.
The study seeks to provide high-level evidence for optimizing pre-transplant conversion strategies for advanced HCC patients currently outside standard transplant criteria.
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- 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 |
|---|---|---|
| Beyond UCSF Criteria Cohort | HCC patients receiving conversion therapy beyond UCSF criteria Receives: Combination Product: Locoregional Therapy (LRT) + Systemic Drug Therapy | |
| Within UCSF Criteria Cohort | HCC patients within UCSF Criteria Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to mRECIST criteria during the conversion therapy period.
Measured: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).
Successful Down-staging Rate to UCSF Criteria
Proportion of patients whose tumor burden is reduced to meet the UCSF transplant criteria after conversion therapy, based on imaging and tumor marker assessment.
Measured: From the start of conversion therapy until the date of meeting UCSF criteria or therapy termination (assessed up to 24 months).
1/2/3-year Overall Survival (OS) Rate
The proportion of patients who received conversion therapy and are still alive at 1, 2, and 3 years after the transplantation surgery, analyzed using the Kaplan-Meier method.
Measured: From the initiation of conversion therapy, assessed at 1, 2, and 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 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, lucaide, Ningbo Medical Center Lihuili Hospital
- Investigators
- Caide Lu, Professor, Principal investigator, Ningbo Medical Centre Lihuili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310836
- Sponsor's protocol ID
- KY2025PJ483
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A specific plan for sharing de-identified individual participant data (IPD) from this retrospective study is under development. The final decision will depend on several factors, including but not limited to: institutional review board (IRB) approval, compliance with data privacy regulations, and the establishment of appropriate data use agreements. If shared, the data would likely include demographic, clinical treatment, tumor response, and survival outcome data to support validation of study findings. The research team is committed to evaluating the possibility of sharing data in a manner that protects participant confidentiality and contributes to scientific knowledge.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. 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 Hepatocellular Carcinoma Beyond UCSF Criteria Before Liver Transplantation
- ClinicalTrials.gov ID
- NCT07310836
- Acronym / sponsor ID
- KY2025PJ483
- Conditions
- Hepatocellular Carcinoma, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 30 Dec 2025 (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 treatment strategy for patients with hepatocellular carcinoma (HCC) who are beyond the UCSF criteria but intended for liver transplantation. The primary objective is to assess the outcomes of these "intention-to-treat" patients who received locoregional therapies (LRT, such as TACE or radiotherapy) in combination with systemic therapy (anti-VEGF/Tyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors) as a "conversion therapy" prior to potential transplantation. This approach is distinct from traditional bridging or down-staging therapies by incorporating more aggressive systemic regimens. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients beyond UCSF criteria who received the combined conversion therapy between January 2020 and December 2024. A control group of about 200 patients who met the UCSF criteria and were directly listed for transplantation in the same period will be used for comparison. Data will be collected from medical records and the China Liver Transplant Registry (CLTR), with follow-up until December 2025.
Primary outcome measures include:
Objective Response Rate (ORR) of conversion therapy per mRECIST. Rate of successful down-staging to meet UCSF criteria.
1-, 2-, and 3-year overall survival (OS) rates of the intention-to-treat population.
Actual liver transplantation rate after successful conversion. Post-transplant 1-, 2-, and 3-year OS and recurrence-free survival (RFS) rates.
Secondary outcomes involve:
Safety profiles of both conversion therapy and subsequent transplantation. Analysis of factors influencing conversion success and treatment efficacy. Determination of an optimal washout period for Immune Checkpoint Inhibitors prior to transplantation.
The study seeks to provide high-level evidence for optimizing pre-transplant conversion strategies for advanced HCC patients currently outside standard transplant criteria.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beyond UCSF Criteria Cohort | – | Combination Product: Locoregional Therapy (LRT) + Systemic Drug TherapyHCC patients receiving conversion therapy beyond UCSF criteria |
| Within UCSF Criteria Cohort | – | –HCC patients within UCSF Criteria Cohort |
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 plans to include 300 patients with HCC. All patients were managed at the study center between January 1, 2020, and December 31, 2024. 1. Beyond UCSF Criteria Cohort (n = 100): Patients with HCC tumors exceeding the UCSF transplant criteria but intended for liver transplantation. All patients in this cohort received multimodal conversion therapy, combining locoregional therapies with systemic therapy. 2. Within UCSF Criteria Cohort (n = 200): A control group of patients whose HCC tumors met the UCSF criteria at the time of listing and were directly registered for liver transplantation without receiving the aforementioned conversion therapy.
Key inclusion criteria (3 listed)
- Age ≥16;
- Clinical diagnosis of HCC;
- CNLC Stage I-IIIA.
Key exclusion criteria (2 listed)
- Extrahepatic metastasis;
- Type IV portal vein tumor thrombus.
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 | Beyond UCSF Criteria Cohort |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the start of conversion therapy until the completion of therapy (assessed up to 24 months).
Proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to mRECIST criteria during the conversion therapy period.
Successful Down-staging Rate to UCSF Criteria
Time frame: From the start of conversion therapy until the date of meeting UCSF criteria or therapy termination (assessed up to 24 months).
Proportion of patients whose tumor burden is reduced to meet the UCSF transplant criteria after conversion therapy, based on imaging and tumor marker assessment.
1/2/3-year Overall Survival (OS) Rate
Time frame: From the initiation of conversion therapy, assessed at 1, 2, and 3 years.
The proportion of patients who received conversion therapy and are still alive at 1, 2, and 3 years after the transplantation surgery, analyzed using the Kaplan-Meier method.
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 30 Dec 2025.
- Individual participant dataSharing planned: Undecided. A specific plan for sharing de-identified individual participant data (IPD) from this retrospective study is under development. The final decision will depend on several factors, including but not limited to: institutional review board (IRB) approval, compliance with data privacy regulations, and the establishment of appropriate data use agreements. If shared, the data would likely include demographic, clinical treatment, tumor response, and survival outcome data to support validation of study findings. The research team is committed to evaluating the possibility of sharing data in a manner that protects participant confidentiality and contributes to scientific knowledge.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Liver Transplantation, run by Ningbo Medical Center Lihuili Hospital.
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 2 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 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Objective Response Rate (ORR) (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 30 Dec 2025.