Hepatecellular CarcinomaNCT07277192
HAIC vs. TACE Combined With ICIs and TKIs in Intermediate-to-Advanced HCC: A Multicenter Study on Liver Injury and Survival
An observational study of Hepatecellular Carcinoma and Liver Injury, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The purpose of this study is to compare the liver injury induced by HAIC combined with PD-1/PD-L1 inhibitors and TKIs versus triple therapy with TACE in the treatment of patients with advanced HCC; to compare the efficacy of the two triple therapy regimens in the treatment of patients with advanced HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatecellular Carcinoma, Liver Injury, HAIC(Hepatic Artery Infusion Chemotherapy)
- How many people
- 562 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intermediate-to-Advanced HCC who received HAIC/TACE combined with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs
Who may be able to join
- Patients voluntarily join this study and sign the informed consent form;
- Aged ≥ 18 years, both male and female;
- Patients with pathologically or clinically confirmed BCLC stage B or C hepatocellular carcinoma (HCC) who were diagnosed between January 1, 2019, and December 31, 2022;
- Receiving treatment with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs are only approved post-market medications, including but not limited to those with HCC indications);
- Transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) completed within 3 months after the first systemic treatment or within 1 month before the first systemic treatment;
- Having at least one measurable intrahepatic lesion, with intrahepatic lesions being the main tumor burden. (According to RECIST v1.1, the measurable lesion has a spiral CT scan long diameter ≥ 10 mm or enlarged lymph node short diameter ≥ 15 mm).
Who cannot join
- Pathologically/histologically confirmed cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma;
- Patients with a history of other malignant tumors within the past 3 years or concurrent malignant tumors (except cured basal cell carcinoma of the skin and cervical in situ carcinoma);
- Concomitant use of other antitumor therapeutic agents, such as antitumor traditional Chinese medicines and proprietary Chinese medicines;
- Patients who do not meet the definition of combination therapy;
- Incomplete medical information, such as lack of post-treatment imaging evaluation;
- Patients with immunodeficiency or those who have undergone organ/bone marrow transplantation;
- Patients deemed unsuitable to participate in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
The purpose of this study is to compare the liver injury induced by HAIC combined with PD-1/PD-L1 inhibitors and TKIs versus triple therapy with TACE in the treatment of patients with advanced HCC; to compare the efficacy of the two triple therapy regimens in the treatment of patients with advanced HCC.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HAIC-group | HAIC combined with ICIs and TKIs | |
| TACE-group | TACE combined with ICIs and TKIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
alanine aminotransferase(ALT)
Measured: Measurements were conducted one week before the first treatment and at regular intervals for up to six months after the intervention, continuing until the occurrence of unacceptable toxicity, withdrawal of consent, or termination of the study by the spon
Secondary outcomes (4)
The median progression free survival time (mPFS)
The progression free survival time defined as the time from the first study dose date to the date of first documentation of disease progression as assessed by RECIST 1.1
Measured: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
The median overall survival time (mOS)
Overall survival rate is measured from the start date of the Treatment Phase (date of first study dose) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes early.
Measured: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
Objective response rate (ORR)
Measured: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
The disease control rate (DCR)
Measured: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatecellular 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinzhang Chen, Study director, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277192
- Sponsor's protocol ID
- NFEC-2023-571
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HAIC vs. TACE Combined With ICIs and TKIs in Intermediate-to-Advanced HCC: A Multicenter Study on Liver Injury and Survival
- ClinicalTrials.gov ID
- NCT07277192
- Acronym / sponsor ID
- NFEC-2023-571
- Conditions
- Hepatecellular Carcinoma, Liver Injury, HAIC(Hepatic Artery Infusion Chemotherapy), TACE(Transcatheter Arterial Chemoembolization)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 562 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 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.
The purpose of this study is to compare the liver injury induced by HAIC combined with PD-1/PD-L1 inhibitors and TKIs versus triple therapy with TACE in the treatment of patients with advanced HCC; to compare the efficacy of the two triple therapy regimens in the treatment of patients with advanced HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC-group | – | –HAIC combined with ICIs and TKIs |
| TACE-group | – | –TACE combined with ICIs and TKIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intermediate-to-Advanced HCC who received HAIC/TACE combined with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs
Key inclusion criteria (6 listed)
- Patients voluntarily join this study and sign the informed consent form;
- Aged ≥ 18 years, both male and female;
- Patients with pathologically or clinically confirmed BCLC stage B or C hepatocellular carcinoma (HCC) who were diagnosed between January 1, 2019, and December 31, 2022;
- Receiving treatment with PD-1/PD-L1 inhibitors combined with anti-angiogenic drugs (both PD-1/PD-L1 inhibitors and targeted drugs are only approved post-market medications, including but not limited to those with HCC indications);
- Transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) completed within 3 months after the first systemic treatment or within 1 month before the first systemic treatment;
Key exclusion criteria (7 listed)
- Pathologically/histologically confirmed cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma;
- Patients with a history of other malignant tumors within the past 3 years or concurrent malignant tumors (except cured basal cell carcinoma of the skin and cervical in situ carcinoma);
- Concomitant use of other antitumor therapeutic agents, such as antitumor traditional Chinese medicines and proprietary Chinese medicines;
- Patients who do not meet the definition of combination therapy;
- Incomplete medical information, such as lack of post-treatment imaging evaluation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
alanine aminotransferase(ALT)
Time frame: Measurements were conducted one week before the first treatment and at regular intervals for up to six months after the intervention, continuing until the occurrence of unacceptable toxicity, withdrawal of consent, or termination of the study by the spon
4 secondary outcomes
The median progression free survival time (mPFS)
Time frame: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
The median overall survival time (mOS)
Time frame: From date of first dose of study drug to the date of first documentation of disease progression or death, whichever occurs first (up to approximately 3 years)
Objective response rate (ORR)
Time frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
The disease control rate (DCR)
Time frame: From date of first dose of study drug until disease progression, stable disease, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years)
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 11 Dec 2025.
- 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.
Jinzhang Chen study director
Nanfang Hospital, Southern Medical University
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 Hepatecellular Carcinoma and Liver Injury, run by Nanfang Hospital, Southern Medical University 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 6 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 11 Dec 2025. 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?
alanine aminotransferase(ALT) (time frame: Measurements were conducted one week before the first treatment and at regular intervals for up to six months after the intervention, continuing until the occurrence of unacceptable toxicity, withdrawal of consent, or termination of the study by the spon). 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 11 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.