Hepatocellular Carcinoma (HCC)NCT07075562
TACE Plus Bevacizumab for Hepatocellular Carcinoma With Portal Vein Invasion
A study testing Bevacizumab Arterial Perfusion plus TACE and Conventional Therapy in people with Hepatocellular Carcinoma (HCC), run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This is a prospective, randomized study designed to compare the efficacy of transcatheter hepatic artery chemoembolization (TACE) combined with bevacizumab arterial perfusion versus conventional therapy in patients with hepatocellular carcinoma (HCC) invading the portal vein. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Bevacizumab Arterial Perfusion plus TACE and Conventional Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 May 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years.
- Confirmed diagnosis of Hepatocellular Carcinoma (HCC) with radiological evidence of portal vein invasion.
- Preserved liver function (Child-Pugh class A or B).
- Absence of severe cardiac, renal, or other vital organ dysfunctions.
- Complete clinical and follow-up data available.
- Provided written informed consent.
Who cannot join
- History of other malignancies within the past five years.
- Prior or planned liver transplantation.
- Severe comorbidities (e.g., decompensated cirrhosis, active bleeding, or cardiac disease).
- Pregnant or lactating women.
- Known hypersensitivity to bevacizumab or other components of the treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050023
About this study
Official title: Effects of Transcatheter Hepatic Arterial Chemoembolization (TACE) and Bevacizumab Arterial Perfusion on Tumor Load and Angiogenesis in Patients With Hepatocellular Carcinoma Invading Portal Vein
This is a prospective, randomized study designed to compare the efficacy of transcatheter hepatic artery chemoembolization (TACE) combined with bevacizumab arterial perfusion versus conventional therapy in patients with hepatocellular carcinoma (HCC) invading the portal vein. The study aims to evaluate the effects on tumor load, angiogenesis, and survival outcomes.
Read the detailed description
Hepatocellular carcinoma (HCC) with portal vein invasion has a poor prognosis and limited therapeutic options. Transcatheter hepatic artery chemoembolization (TACE) is a standard locoregional therapy, but its efficacy can be limited by hypoxia-induced angiogenesis. Bevacizumab, a VEGF inhibitor, can counteract this angiogenic rebound. This study was designed to investigate the potential synergistic effects of combining TACE with bevacizumab arterial perfusion. A total of 180 patients with portal vein-invasive HCC were prospectively recruited and randomized to either the combination therapy group or a conventional therapy control group. The primary objectives were to assess changes in tumor load (size and number), serum angiogenic factors (VEGF and PDGF), and tumor vascular density. Secondary objectives included evaluating safety and comparing progression-free and overall survival between the two groups to establish an evidence-based framework for this treatment strategy.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Bevacizumab Arterial Perfusion plus TACE, Conventional 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.
Bevacizumab Arterial Perfusion plus TACEDrug
The intervention consists of a combination treatment. Patients undergo transcatheter hepatic artery chemoembolization (TACE), a procedure involving localized delivery of chemotherapy and embolization of the tumor-feeding arteries. This is combined with a targeted arterial perfusion of bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF).
Conventional TherapyProcedure or surgery
Patients in the control group received conventional therapy, which typically consists of TACE alone for this patient population. This involves the selective catheterization of hepatic arteries supplying the tumor, followed by the infusion of chemotherapeutic agents and an embolic agent to induce tumor necrosis.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Observation Group (TACE + Bevacizumab) | Experimental | Patients randomized to this arm received transcatheter hepatic artery chemoembolization (TACE) combined with arterial infusion of bevacizumab. Receives: Drug: Bevacizumab Arterial Perfusion plus TACE |
| Active Comparator: Control Group (Conventional Therapy) | Active comparator | Patients randomized to this arm received conventional therapy for HCC with portal vein invasion, serving as the active control. Receives: Procedure: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tumor Load
Measured by assessing the change in tumor diameter (in cm) and the total number of tumors from baseline. Measurements are performed using Magnetic Resonance Imaging (MRI).
Measured: Baseline (before treatment) and 3 months post-treatmen
Change in Serum Angiogenic Factors
Measured by the change in serum levels of Vascular Endothelial Growth Factor (VEGF) and Platelet-Derived Growth Factor (PDGF) in pg/mL, as quantified by Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: Baseline (before treatment) and at the 3-month post-treatment follow-up
Change in Tumor Vascular Density
Measured as the change in the density of blood vessels (vessels/cm²) in the tumor area, evaluated by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI).
Measured: Baseline (before treatment) and 3 months post-treatment
Secondary outcomes (3)
Overall Survival (OS)
Time from randomization to death from any cause. Reported as median survival in months.
Measured: From date of randomization until death, with a median follow-up of 24 months (range 12-36 months)
Progression-Free Survival (PFS)
Time from randomization to disease progression or death from any cause, whichever occurs first. Reported as median survival in months.
Measured: From date of randomization until disease progression or death, assessed at 6-month intervals up to 36 months
Incidence of Adverse Events
Number and percentage of participants experiencing treatment-related adverse events, graded according to CTCAE v5.0.
Measured: From the start of the first intervention until the 3-month post-treatment follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Jun 2021
- Primary completion31 Mar 2024
- Study completion30 May 2025
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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bingzheng Yan, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075562
- Sponsor's protocol ID
- 20220685
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcatheter Hepatic Arterial Chemoembolization (TACE) and Bevacizumab Arterial Perfusion on Tumor Load and Angiogenesis in Patients With Hepatocellular Carcinoma Invading Portal Vein
- ClinicalTrials.gov ID
- NCT07075562
- Acronym / sponsor ID
- 20220685
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 20 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 is a prospective, randomized study designed to compare the efficacy of transcatheter hepatic artery chemoembolization (TACE) combined with bevacizumab arterial perfusion versus conventional therapy in patients with hepatocellular carcinoma (HCC) invading the portal vein. The study aims to evaluate the effects on tumor load, angiogenesis, and survival outcomes.
Detailed description
Hepatocellular carcinoma (HCC) with portal vein invasion has a poor prognosis and limited therapeutic options. Transcatheter hepatic artery chemoembolization (TACE) is a standard locoregional therapy, but its efficacy can be limited by hypoxia-induced angiogenesis. Bevacizumab, a VEGF inhibitor, can counteract this angiogenic rebound. This study was designed to investigate the potential synergistic effects of combining TACE with bevacizumab arterial perfusion. A total of 180 patients with portal vein-invasive HCC were prospectively recruited and randomized to either the combination therapy group or a conventional therapy control group. The primary objectives were to assess changes in tumor load (size and number), serum angiogenic factors (VEGF and PDGF), and tumor vascular density. Secondary objectives included evaluating safety and comparing progression-free and overall survival between the two groups to establish an evidence-based framework for this treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Observation Group (TACE + Bevacizumab) | Experimental | Drug: Bevacizumab Arterial Perfusion plus TACEPatients randomized to this arm received transcatheter hepatic artery chemoembolization (TACE) combined with arterial infusion of bevacizumab. |
| Active Comparator: Control Group (Conventional Therapy) | Active comparator | Procedure: Conventional TherapyPatients randomized to this arm received conventional therapy for HCC with portal vein invasion, serving as the active control. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 70 years.
- Confirmed diagnosis of Hepatocellular Carcinoma (HCC) with radiological evidence of portal vein invasion.
- Preserved liver function (Child-Pugh class A or B).
- Absence of severe cardiac, renal, or other vital organ dysfunctions.
- Complete clinical and follow-up data available.
Key exclusion criteria (5 listed)
- History of other malignancies within the past five years.
- Prior or planned liver transplantation.
- Severe comorbidities (e.g., decompensated cirrhosis, active bleeding, or cardiac disease).
- Pregnant or lactating women.
- Known hypersensitivity to bevacizumab or other components of the 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 |
|---|---|---|
| Bevacizumab Arterial Perfusion plus TACEThe intervention consists of a combination treatment. Patients undergo transcatheter hepatic artery chemoembolization (TACE), a procedure involving localized delivery of chemotherapy and embolization of the tumor-feeding arteries. This is combined with a targeted arterial perfusion of bevacizumab, a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF). | Drug | Experimental: Observation Group (TACE + Bevacizumab) |
| Conventional TherapyPatients in the control group received conventional therapy, which typically consists of TACE alone for this patient population. This involves the selective catheterization of hepatic arteries supplying the tumor, followed by the infusion of chemotherapeutic agents and an embolic agent to induce tumor necrosis. | Procedure or surgery | Active Comparator: Control Group (Conventional Therapy) |
Primary outcome
Change in Tumor Load
Time frame: Baseline (before treatment) and 3 months post-treatmen
Measured by assessing the change in tumor diameter (in cm) and the total number of tumors from baseline. Measurements are performed using Magnetic Resonance Imaging (MRI).
Change in Serum Angiogenic Factors
Time frame: Baseline (before treatment) and at the 3-month post-treatment follow-up
Measured by the change in serum levels of Vascular Endothelial Growth Factor (VEGF) and Platelet-Derived Growth Factor (PDGF) in pg/mL, as quantified by Enzyme-Linked Immunosorbent Assay (ELISA).
Change in Tumor Vascular Density
Time frame: Baseline (before treatment) and 3 months post-treatment
Measured as the change in the density of blood vessels (vessels/cm²) in the tumor area, evaluated by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI).
3 secondary outcomes
Overall Survival (OS)
Time frame: From date of randomization until death, with a median follow-up of 24 months (range 12-36 months)
Progression-Free Survival (PFS)
Time frame: From date of randomization until disease progression or death, assessed at 6-month intervals up to 36 months
Incidence of Adverse Events
Time frame: From the start of the first intervention until the 3-month post-treatment follow-up visit
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 20 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.
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?
A study testing Bevacizumab Arterial Perfusion plus TACE and Conventional Therapy 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 6 inclusion and 5 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 20 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?
Change in Tumor Load (time frame: Baseline (before treatment) and 3 months post-treatmen). 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 20 Jul 2025.