Hepatocellular CarcinomaNCT06898398
TACE Combined Surgery for the Resectable Huge HCC
An observational study of Hepatocellular Carcinoma and Hepatic Chemotherapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer
- What is being tested?
- TACE and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 326 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a multicenter, observational real-world study to compare the efficacy of TACE with surgery inhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy combined surgery. This study will create a database that will provide clinical parameters and outcomes of patients undergoing combined therapy for huge HCC therapy.
Who may be able to join
- clinical or pathological diagnosis of primary HCC;
- tumor diameter > 10 cm on images before inclusion;
- age 18 to 75 years;
- no macrovascular invasion or extrahepatic metastasis;
- liver resection with complete removal of the tumor and adequate remnant liver volume;
- albumin-bilirubin (ALBI) grade I and II;
Show all 9Show fewer
- Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
- hemoglobin level ≥ 8.5 g/dL, total bilirubin level ≤ 30 mmol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) levels ≤ 5 × upper limit of normal, serum creatinine level ≤ 1.5 × upper limit of normal;
- prothrombin time ≤ 18 s or international normalized ratio < 1.7.
Who cannot join
- HCC with macrovascular invasion or extrahepatic metastasis;
- tumor with a maximum diameter ≤ 10 cm on images before inclusion;
- recurrent HCC;
- serious medical comorbidities;
- portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
- cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
- incomplete data or lost to follow-up within three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Feng Duan, MD contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA general hospital
Beijing, Beijing Municipality, 100853
Qunfang Zhou, MD, 8619868000115, zhouqun988509@163.com
Feng Duan, MD, 8613910984586, duanfeng@vip.sina.com
About this study
Official title: Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. The high risk of recurrence after surgery is another challenge for surgeons. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.
Read the detailed description
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. However, the 2-year recurrence rate in such cases is as high as 70%, indicating the need for more effective interventions to improve outcomes. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The impact of neoadjuvant TACE on the long-term oncological outcomes of huge HCC requires investigation. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.
- Conditions
- Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer, Surgery
- Being tested
- TACE, Surgery
- Keywords
- huge hepatocellular carcinoma, TACE, Surgery
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
SurgeryProcedure or surgery
The surgical plan was based on the tumor size, tumor location, and liver function. We applied Pringle's maneuver with cycles of clamping and unclamping times of 1-10 and 5 min, respectively, and maintained the central venous pressure below 4 mmHg during parenchymal dissection to control intraoperative bleeding.
| Study group | Role | What they receive |
|---|---|---|
| TACE+surgery | patients underwent neoadjuvant TACE followed by surgical treatment. Receives: Procedure: TACE; Procedure: Surgery | |
| Surgery | patients underwent surgical treatment. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival （RFS）
RFS was defined as the time from surgery to tumor progression or the last follow-up
Measured: 24 months
Secondary outcomes (1)
Overall survival (OS)
OS was defined as the time from surgery to death or the last follow-up
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Jan 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Feng Duan, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898398
- Sponsor's protocol ID
- Liver Project 15
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Arterial Chemoembolization Combined Surgery Versus Surgery for the Resectable Huge Hepatocellular Carcinoma: a Multicenter Propensity Analysis
- ClinicalTrials.gov ID
- NCT06898398
- Acronym / sponsor ID
- Liver Project 15
- Conditions
- Hepatocellular Carcinoma, Hepatic Chemotherapy, Liver Cancer, Surgery
- Keywords
- huge hepatocellular carcinoma, TACE, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Mar 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.
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. The high risk of recurrence after surgery is another challenge for surgeons. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.
Detailed description
Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. However, the 2-year recurrence rate in such cases is as high as 70%, indicating the need for more effective interventions to improve outcomes. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The impact of neoadjuvant TACE on the long-term oncological outcomes of huge HCC requires investigation. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+surgery | – | Procedure: TACE, Procedure: Surgerypatients underwent neoadjuvant TACE followed by surgical treatment. |
| Surgery | – | Procedure: Surgerypatients underwent surgical treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a multicenter, observational real-world study to compare the efficacy of TACE with surgery inhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy combined surgery. This study will create a database that will provide clinical parameters and outcomes of patients undergoing combined therapy for huge HCC therapy.
Key inclusion criteria (9 listed)
- clinical or pathological diagnosis of primary HCC;
- tumor diameter > 10 cm on images before inclusion;
- age 18 to 75 years;
- no macrovascular invasion or extrahepatic metastasis;
- liver resection with complete removal of the tumor and adequate remnant liver volume;
Key exclusion criteria (7 listed)
- HCC with macrovascular invasion or extrahepatic metastasis;
- tumor with a maximum diameter ≤ 10 cm on images before inclusion;
- recurrent HCC;
- serious medical comorbidities;
- portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
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 |
|---|---|---|
| TACETACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure. | Procedure or surgery | TACE+surgery |
| SurgeryThe surgical plan was based on the tumor size, tumor location, and liver function. We applied Pringle's maneuver with cycles of clamping and unclamping times of 1-10 and 5 min, respectively, and maintained the central venous pressure below 4 mmHg during parenchymal dissection to control intraoperative bleeding. | Procedure or surgery | Surgery, TACE+surgery |
Primary outcome
Recurrence-free survival （RFS）
Time frame: 24 months
RFS was defined as the time from surgery to tumor progression or the last follow-up
1 secondary outcome
Overall survival (OS)
Time frame: 60 months
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 3 Apr 2025.
Related trials for Hepatocellular Carcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
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.
Feng Duan, MD contact
Feng Duan, MD principal investigator
Chinese PLA General 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 Hepatic Chemotherapy, run by Sun Yat-sen 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 9 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: looking for participants now, as of the sponsor's last update on 3 Apr 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?
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 Qunfang Zhou, MD (19868000115, zhouqun988509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival （RFS） (time frame: 24 months). 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 3 Apr 2025.