Hepatocellular CarcinomaNCT06823050
A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced HCC with DEB-TACE Combined with SALOX-HAIC
An observational study of Hepatocellular Carcinoma, run by Xuhua Duan at 7 sites in China.
Trial summary
The aim of this study is to clarify the safety and efficacy of DEB-TACE combined with SALOX-HAIC in the treatment of unresectable advanced primary liver cancer. To determine whether this therapy can prolong the indicators such as PFS, TTP, OS, ORR, and DOR. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 59 participants
- Where
- 7 sitesChina
- Study dates
- 1 Mar 2025to 28 Feb 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: unresectable advanced HCC
Who may be able to join
- 1. Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).
- 2. CNLC Ib-IIIa；BCLC：A-C 3. Patient age between 18 and 80，male or female. 4. ECOG 0-1. 5.Expected life span ≥ 3 months. 6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
- 7. Child-Pugh A-B. 8.The laboratory tests meet the following requirements: platelets ≥ 50×109/L; hemoglobin ≥ 9g/dL; white blood cells ≥ 4×109/L; neutrophils ≥ 1.5×109/L; serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine test shows that urine protein < 2+; for patients whose urine routine test at baseline showed urine protein ≥ 2+, 24-hour urine collection should be conducted and the 24-hour urine protein quantification should be < 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
- 9. HBV DNA<2000 IU/ml. 10. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
- 11. Patients sign informed consent, good compliance, cooperate with treatment.
Who cannot join
- 1. Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.
- 2. Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.
- 3. Diffuse liver cancer patients. 4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
- 5. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
- 6. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
- 7. Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.
- 8. Systemic failure, estimated survival time <3 months. 9. Severe renal dysfunction. 10. The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Deng zhou People's Hospital
Dengzhou, Henan
Yanliang Li
The Second People's Hospital of Jiaozuo
Jiaozuo, Henan
Chuntang Qin
Huai He Hospital of Henan University
Kaifeng, Henan
Xiang He
Luo Yang Central Hospital
Luoyang, Henan
Fazhong Li, 18537919361
First People's Hospital of Shangqiu
Shangqiu, Henan
Zhenhua Tian
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Xuhua Duan, +8613523402912, xuhuaduan@163.com
Zhou Kou Central Hospital
Zhoukou, Henan
Cheng Xing, +8618336547709
About this study
Official title: A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced Hepatocellular Carcinoma with the DEB-TACE (drug-loaded Microsphere Transcatheter Arterial Chemoembolization) Combined with Hepatic Artery Perfusion of Raltitrexed and Oxaliplatin (SALOX-HAIC) Regimen
The aim of this study is to clarify the safety and efficacy of DEB-TACE combined with SALOX-HAIC in the treatment of unresectable advanced primary liver cancer. To determine whether this therapy can prolong the indicators such as PFS, TTP, OS, ORR, and DOR.
- Conditions
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
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 |
|---|---|---|
| DEB-TACE+ SALOX-HAIC+Apatinib+Carilizumab | Drug-eluting bead transarterial chemoembolization combined with SALOX-HAIC sequential Apatinib and Carilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Measured: Time from the first DEB-TACE treatment to either radiological progression or death or up to 24 months
Secondary outcomes (4)
Overall survival (OS)
Measured: Time Frame: Time from the first DEB-TACE treatment to death or up to 24 months
Objective response rate (ORR)
Measured: 1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first.
Disease control rate (DCR)
Measured: 1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first
Time to Progression (TTP)
Measured: Time from the first DEB-BACE treatment to either radiological progression 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 posted12 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion28 Feb 2028 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuhua Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuhua Duan, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823050
- Sponsor's protocol ID
- 2025-KY-0112-001
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 12 Feb 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Phase II Clinical Study on the Treatment of Unresectable Advanced Hepatocellular Carcinoma with the DEB-TACE (drug-loaded Microsphere Transcatheter Arterial Chemoembolization) Combined with Hepatic Artery Perfusion of Raltitrexed and Oxaliplatin (SALOX-HAIC) Regimen
- ClinicalTrials.gov ID
- NCT06823050
- Acronym / sponsor ID
- 2025-KY-0112-001
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Xuhua DuanUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 12 Feb 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 aim of this study is to clarify the safety and efficacy of DEB-TACE combined with SALOX-HAIC in the treatment of unresectable advanced primary liver cancer. To determine whether this therapy can prolong the indicators such as PFS, TTP, OS, ORR, and DOR.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEB-TACE+ SALOX-HAIC+Apatinib+Carilizumab | – | –Drug-eluting bead transarterial chemoembolization combined with SALOX-HAIC sequential Apatinib and Carilizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unresectable advanced HCC
Key inclusion criteria (5 listed)
- 1. Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).
- 2. CNLC Ib-IIIa；BCLC：A-C 3. Patient age between 18 and 80，male or female. 4. ECOG 0-1. 5.Expected life span ≥ 3 months. 6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
- 7. Child-Pugh A-B. 8.The laboratory tests meet the following requirements: platelets ≥ 50×109/L; hemoglobin ≥ 9g/dL; white blood cells ≥ 4×109/L; neutrophils ≥ 1.5×109/L; serum total bilirubin ≤ 1.5 times the upper limit of normal value (ULN), transaminases (ALT, AST) ≤ 5 times ULN; creatinine ≤ 1.5 times ULN; urine routine test shows that urine protein < 2+; for patients whose urine routine test at baseline showed urine protein ≥ 2+, 24-hour urine collection should be conducted and the 24-hour urine protein quantification should be < 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
- 9. HBV DNA<2000 IU/ml. 10. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
- 11. Patients sign informed consent, good compliance, cooperate with treatment.
Key exclusion criteria (7 listed)
- 1. Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.
- 2. Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.
- 3. Diffuse liver cancer patients. 4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
- 5. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
- 6. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
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
Progression-free survival (PFS)
Time frame: Time from the first DEB-TACE treatment to either radiological progression or death or up to 24 months
4 secondary outcomes
Overall survival (OS)
Time frame: Time Frame: Time from the first DEB-TACE treatment to death or up to 24 months
Objective response rate (ORR)
Time frame: 1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first.
Disease control rate (DCR)
Time frame: 1, 3, 6,12,18,24 months after the first DEB-TACE treatment, up to death or 24 months, whichever came first
Time to Progression (TTP)
Time frame: Time from the first DEB-BACE treatment to either radiological progression up to 24 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 12 Feb 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.
7 sites 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, run by Xuhua Duan at 7 sites 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 5 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: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Hua Xu Xuhua Duan (13523402912, xuhuaduan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Time from the first DEB-TACE treatment to either radiological progression or death or up to 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 12 Feb 2025.