Hepatocellular Carcinoma (HCC)NCT07053202
TACE With Immune Agents for Angiogenesis in Hepatocellular Carcinoma
A study testing Nivolumab and Transarterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC), run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This study investigates the clinical efficacy and safety of transarterial chemoembolization (TACE) combined with the immune agent nivolumab compared to TACE alone for treating hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Nivolumab and Transarterial Chemoembolization (TACE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age >18 years;
- Diagnosis of HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition), confirmed by pathological examination;
- Barcelona Clinic Liver Cancer (BCLC) stages A, B, and C, with non-resectable tumors;
- Liver function graded as Child-Pugh A or B;
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- No severe hematologic abnormalities or immune deficiencies;
- Expected survival time >6 months.
Who cannot join
- Recurrent liver cancer or metastatic cancer from other organs;
- Previous treatment with other antitumor therapies, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy;
- History of other malignant tumors;
- Pregnant or lactating women;
- Human immunodeficiency virus (HIV) infection;
- Severe cardiovascular, pulmonary, cerebral, or renal diseases;
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- Active bleeding or coagulopathy outside the liver;
- Enrollment in another clinical trial or participation in a clinical trial within one month prior to admission;
- Psychiatric disorders or unstable mental status;
- Allergic reactions to the study drugs;
- Severe gastrointestinal diseases, such as active ulcers, or other conditions affecting drug absorption.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
About this study
Official title: Clinical Study on TACE Combined With Immune Agents for Inhibiting Tumor Angiogenesis in Hepatocellular Carcinoma
This study investigates the clinical efficacy and safety of transarterial chemoembolization (TACE) combined with the immune agent nivolumab compared to TACE alone for treating hepatocellular carcinoma (HCC). The study aims to determine if the combination therapy can more effectively inhibit tumor angiogenesis, improve clinical benefit rates, and prolong survival, while maintaining a high safety profile.
Read the detailed description
Hepatocellular carcinoma (HCC) is a common malignancy with high mortality. While TACE is a standard treatment, it can paradoxically stimulate tumor angiogenesis. Immune checkpoint inhibitors have shown promise in HCC, but single-agent efficacy is limited. This study was designed to evaluate whether combining TACE with hepatic arterial infusion of an immune agent (nivolumab) could improve outcomes by inhibiting tumor angiogenesis and enhancing anti-tumor immune responses. Patients diagnosed with unresectable HCC (BCLC stages A, B, C; Child-Pugh A or B) were randomized to receive either TACE alone (control group) or TACE combined with hepatic arterial infusion of nivolumab (study group). The study assessed objective response rate (ORR), disease control rate (DCR), changes in angiogenesis factors (VEGF, VEGFR-2, Ang-2) and tumor markers (CEA, AFP, CA199) before and one month after treatment. Adverse reactions, overall survival (OS), and progression-free survival (PFS) were also evaluated.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Nivolumab, Transarterial Chemoembolization (TACE)
- Keywords
- TACE, Immune agents, Hepatic arterial infusion, Hepatocellular carcinoma, Tumor angiogenesis, Nivolumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabCombination product
hepatic artery infusion therapy with nivolumab was performed
Transarterial Chemoembolization (TACE)Procedure or surgery
Seldinger technique for femoral artery puncture. Catheterization to celiac trunk/hepatic artery. Infusion of a mixture of idarubicin, raltitrexed, iodized oil, and contrast agent (approx. 8 mL). Embolization with microspheres (300-500 μm and 500-700 μm).
| Study group | Role | What they receive |
|---|---|---|
| TACE combined with Nivolumab | Experimental | Patients received TACE procedure. Additionally, hepatic artery infusion therapy with nivolumab was performed. Receives: Combination Product: Nivolumab; Procedure: Transarterial Chemoembolization (TACE) |
| TACE Alone | Active comparator | Patients received TACE procedure alone. Receives: Procedure: Transarterial Chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of patients achieving Complete Remission (CR) or Partial Remission (PR) based on RECIST 1.1 criteria. ORR = [(CR + PR) / total cases] × 100%.
Measured: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Disease Control Rate (DCR)
Percentage of patients achieving CR, PR, or Stable Disease (SD) based on RECIST 1.1 criteria. DCR = [(CR + PR + SD) / total cases] × 100%.
Measured: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Secondary outcomes (9)
Level of Vascular Endothelial Growth Factor (VEGF)
Serum level of Vascular Endothelial Growth Factor (VEGF) measured by ELISA.
Measured: Baseline (one day before treatment) and 1 month after treatment.
Level of VEGF Receptor-2 (VEGFR-2)
Serum level of VEGF Receptor-2 (VEGFR-2) measured by ELISA.
Measured: Baseline (one day before treatment) and 1 month after treatment.
Level of Angiopoietin-2 (Ang-2)
Serum level of Angiopoietin-2 (Ang-2) measured by ELISA.
Measured: Baseline (one day before treatment) and 1 month after treatment.
Level of Carcinoembryonic Antigen (CEA)
Serum level of Carcinoembryonic Antigen (CEA) measured by ELISA.
Measured: Baseline (one day before treatment) and 1 month after treatment.
Level of Alpha-fetoprotein (AFP)
Serum level of Alpha-fetoprotein (AFP) measured by ELISA.
Measured: Baseline (one day before treatment) and 1 month after treatment.
Level of Carbohydrate Antigen 199 (CA199)
Serum level of Carbohydrate Antigen 199 (CA199) measured by ELISA.
Measured: Baseline (one day before treatment) and 1 month after treatment.
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: From randomization until death or end of study, whichever comes first, up to December 2023 (median follow-up 13.87 months).
Progression-Free Survival (PFS)
Time from randomization to disease progression (as per RECIST 1.1) or death from any cause.
Measured: From randomization until disease progression or death, whichever comes first, up to December 2023 (median follow-up 13.87 months).
Incidence of Adverse Reactions
Adverse reactions evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From the first day of treatment until 30 days after the last treatment administration, monitored up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Oct 2021
- Primary completion1 Nov 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhua Ma, The First Hospital of Hebei Medical University
- Investigators
- Wenhua Ma, Principal investigator, Department of Oncology, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053202
- Sponsor's protocol ID
- 2021-B-035
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on TACE Combined With Immune Agents for Inhibiting Tumor Angiogenesis in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07053202
- Acronym / sponsor ID
- 2021-B-035
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- TACE, Immune agents, Hepatic arterial infusion, Hepatocellular carcinoma, Tumor angiogenesis, Nivolumab
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Jul 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 study investigates the clinical efficacy and safety of transarterial chemoembolization (TACE) combined with the immune agent nivolumab compared to TACE alone for treating hepatocellular carcinoma (HCC). The study aims to determine if the combination therapy can more effectively inhibit tumor angiogenesis, improve clinical benefit rates, and prolong survival, while maintaining a high safety profile.
Detailed description
Hepatocellular carcinoma (HCC) is a common malignancy with high mortality. While TACE is a standard treatment, it can paradoxically stimulate tumor angiogenesis. Immune checkpoint inhibitors have shown promise in HCC, but single-agent efficacy is limited. This study was designed to evaluate whether combining TACE with hepatic arterial infusion of an immune agent (nivolumab) could improve outcomes by inhibiting tumor angiogenesis and enhancing anti-tumor immune responses. Patients diagnosed with unresectable HCC (BCLC stages A, B, C; Child-Pugh A or B) were randomized to receive either TACE alone (control group) or TACE combined with hepatic arterial infusion of nivolumab (study group). The study assessed objective response rate (ORR), disease control rate (DCR), changes in angiogenesis factors (VEGF, VEGFR-2, Ang-2) and tumor markers (CEA, AFP, CA199) before and one month after treatment. Adverse reactions, overall survival (OS), and progression-free survival (PFS) were also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE combined with Nivolumab | Experimental | Combination Product: Nivolumab, Procedure: Transarterial Chemoembolization (TACE)Patients received TACE procedure. Additionally, hepatic artery infusion therapy with nivolumab was performed. |
| TACE Alone | Active comparator | Procedure: Transarterial Chemoembolization (TACE)Patients received TACE procedure alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >18 years;
- Diagnosis of HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition), confirmed by pathological examination;
- Barcelona Clinic Liver Cancer (BCLC) stages A, B, and C, with non-resectable tumors;
- Liver function graded as Child-Pugh A or B;
- At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
Key exclusion criteria (11 listed)
- Recurrent liver cancer or metastatic cancer from other organs;
- Previous treatment with other antitumor therapies, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy;
- History of other malignant tumors;
- Pregnant or lactating women;
- Human immunodeficiency virus (HIV) infection;
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 |
|---|---|---|
| Nivolumabhepatic artery infusion therapy with nivolumab was performed | Combination product | TACE combined with Nivolumab |
| Transarterial Chemoembolization (TACE)Seldinger technique for femoral artery puncture. Catheterization to celiac trunk/hepatic artery. Infusion of a mixture of idarubicin, raltitrexed, iodized oil, and contrast agent (approx. 8 mL). Embolization with microspheres (300-500 μm and 500-700 μm). | Procedure or surgery | TACE Alone, TACE combined with Nivolumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Percentage of patients achieving Complete Remission (CR) or Partial Remission (PR) based on RECIST 1.1 criteria. ORR = [(CR + PR) / total cases] × 100%.
Disease Control Rate (DCR)
Time frame: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, up to 24 months.
Percentage of patients achieving CR, PR, or Stable Disease (SD) based on RECIST 1.1 criteria. DCR = [(CR + PR + SD) / total cases] × 100%.
9 secondary outcomes
Level of Vascular Endothelial Growth Factor (VEGF)
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of VEGF Receptor-2 (VEGFR-2)
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Angiopoietin-2 (Ang-2)
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Carcinoembryonic Antigen (CEA)
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Alpha-fetoprotein (AFP)
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Level of Carbohydrate Antigen 199 (CA199)
Time frame: Baseline (one day before treatment) and 1 month after treatment.
Overall Survival (OS)
Time frame: From randomization until death or end of study, whichever comes first, up to December 2023 (median follow-up 13.87 months).
Progression-Free Survival (PFS)
Time frame: From randomization until disease progression or death, whichever comes first, up to December 2023 (median follow-up 13.87 months).
Incidence of Adverse Reactions
Time frame: From the first day of treatment until 30 days after the last treatment administration, monitored up to 24 months.
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 8 Jul 2025.
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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.
Wenhua Ma principal investigator
Department of Oncology, The First Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab and Transarterial Chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC), run by The First Hospital of Hebei 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 8 inclusion and 11 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 8 Jul 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?
Objective Response Rate (ORR) (time frame: Assessed at 1 month post-treatment, and then approximately every 3 months until disease progression, 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?
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 8 Jul 2025.