CarcinomaNCT07180459
The Treatment of Unresectable Liver Cancer With E-TACE Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study
An observational study of Carcinoma and Hepatocellular Carcinoma, run by Xuhua Duan at 10 sites in China.
Trial summary
To clarify the safety and efficacy of using uniform-sized drug-loaded embolic microspheres (E-TACE) of different particle sizes for graded embolization during TACE combined with Donafenib in the treatment of unresectable primary liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Hepatocellular Carcinoma
- What is being tested?
- E-TACE and Donafenib
- Type of treatment
- Surgery or procedure
- How many people
- 118 participants
- Where
- 10 sitesChina
- Study dates
- 10 Oct 2025to 10 Oct 2027
- How long will I take part?
- 1 Year
- 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: 118 Hepatocellular carcinoma Patients
Who may be able to join
- (1) Patients with unresectable primary liver cancer who strictly meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines" (2024 Edition) or who have been diagnosed through pathological histology or cytology examination, and who have at least one measurable lesion (according to the mRECIST 1.1 version, the long diameter of the measurable lesion on spiral CT scan should be ≥ 10mm or the short diameter of the enlarged lymph node should be ≥ 15mm); (2) Tumor staging: CNLC stage Ib, IIa, IIb, IIIa, IIIb or BCLC A, B, C stage; non-diffuse liver cancer (PVTT classified according to the Japanese Liver Cancer Research Society's portal vein tumor thrombus characteristics as Vp1/2, Vp3, Vp4); (3) Gender of the patients is not restricted, and the age is 18-80 years old; expected lifespan is ≥ 3 months; (4) Within 1 week before enrollment, the ECOG PS score: 0-1; (5) No severe comorbidities, such as hypertension, coronary heart disease and history of mental illness, no severe allergy history; (6) Liver function should reach Child-Pugh grade A or B; (7) 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 shows urine protein < 2+; for patients whose urine protein ≥ 2+ at baseline, 24-hour urine collection should be conducted and the 24-hour urine protein quantification < 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; (8) HBV DNA < 2000 IU/ml (104 copies/ml); (9) For pregnant women of childbearing age, a pregnancy test should be conducted within 7 days before enrollment; (10) Patients have signed the informed consent form agreeing to participate in this trial study; good compliance and cooperation with treatment.
Who cannot join
- (1) Imaging examination shows that the liver tumor is huge (≥ 60% of liver volume), or there is a main portal vein tumor thrombus (occupying the vascular diameter ≥ 50%), or the tumor thrombus invades the mesenteric vein or inferior vena cava, or there are obvious native hepatic artery - portal vein fistulas and native hepatic artery - hepatic vein fistulas that cannot safely use drug-loaded microspheres; (2) Before participating in this study, they have undergone local treatments such as traditional TACE, thermal ablation, cryoablation, external radiotherapy and radioactive particle implantation, and have received systemic chemotherapy, oral liver cancer targeted drugs (sorafenib, lenafolate, apatinib) and immune therapy (PD-1/PD-L1/CDLA-4/biologic double therapy); (3) Patients with diffuse liver cancer; known hepatocellular carcinoma and mixed cell carcinoma and fibroplastic cell carcinoma; having other untreated malignant tumors in the past (within 5 years) or simultaneously; except for cured skin basal cell carcinoma and cervical carcinoma in situ; (4) Having grade II or above myocardial ischemia or myocardial infarction, and uncontrolled arrhythmia (including QTc interval for males ≥ 450ms, females ≥ 470ms); (5) Having a history of gastrointestinal bleeding in the past 6 months or having a clear tendency for gastrointestinal bleeding, such as: esophageal varices with bleeding risk, local active ulcer lesion, fecal occult blood ≥ (++), not eligible for inclusion; if fecal occult blood (+), a gastroscopy examination is required; (6) Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), bleeding tendency or undergoing thrombolysis or anticoagulation treatment; (7) Patients with central nervous system metastasis or known brain metastasis; having objective evidence of past and current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of pulmonary function; patients with combined HIV infection; pregnant or lactating patients; patients preparing for liver transplantation (except for patients who have undergone liver transplantation in the past); (8) Severe systemic failure, with an expected survival period < 3 months; (9) Severe renal dysfunction (creatinine > 2mg/dl or creatinine clearance rate < 30ml/min); (10) Unable to complete the treatment plan due to various reasons, and lost follow-up within three months after enrollment.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
People's Hospital of Kaiyang County
Guiyang, Guizhou
The Second Affiliated Hospital of Hainan Medical Universsity
Haikou, Hainan
Second People's Hospital of Jiaozuo
Jiaozuo
Huai He Hospital of Henan University
Kaifeng, Henan
Luo He Central Hospital
Luohe, Henan
Luo Yang Central Hospital
Luoyang, Henan
Jiangxi Provincial People's Hospitail
Nanchang, Jiangxi
Deng zhou People's Hospital
Nanyang, Henan
First People's Hospital of Shangqiu
Shangqiu, Henan
Zhou Kou Central Hospital
Zhoukou, Henan
About this study
Official title: The Treatment of Unresectable Liver Cancer With Graded Embolization of Uniform-sized Drug-loaded Microspheres Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study
To clarify the safety and efficacy of using uniform-sized drug-loaded embolic microspheres (E-TACE) of different particle sizes for graded embolization during TACE combined with Donafenib in the treatment of unresectable primary liver cancer. To determine whether this therapy can prolong the ORR, DCR, PFS, OS and other indicators.
- Conditions
- Carcinoma, Hepatocellular Carcinoma
- Being tested
- E-TACE, Donafenib
- Medical subject headings
- Carcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-TACEProcedure or surgery
The 70/100μm drug-loaded microspheres were loaded with anthracyclines (30mg-50mg Idarubicin) at 2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded anthracyclines (30mg-50mg Idarubicin) with 2mL/3mLto embolize the tumor supplying arteries at different grades and diameters.
DonafenibDrug
400mg QD
| Study group | Role | What they receive |
|---|---|---|
| E-TACE in Combination with Donafenib | Not described Receives: Procedure: E-TACE; Drug: Donafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The definition of PFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.
Measured: up to 1 year
Secondary outcomes (4)
ORR
ORR is defined as the proportion of patients who achieve complete remission (CR, Complete Response) and partial remission (PR, Partial Response) according to the mRECIST criteria
Measured: up to 1 year
OS
The OS is defined as the time from the first administration of combined therapy to the occurrence of any cause of death. If there is no death record for the patient, the last visit time will be used as the censored value.
Measured: up to1 year
TTP
The TTP is defined as the time from the first administration of combined therapy to the first imaging assessment revealing tumor progression
Measured: up to1 year
AE
Adverse Events
Measured: up to1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 118 participants (estimated)
- Target duration
- 1 Year
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
- NCT07180459
- Sponsor's protocol ID
- 2025-KY-1085-002
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Unresectable Liver Cancer With Graded Embolization of Uniform-sized Drug-loaded Microspheres Combined With Donafenib：A Prospective, Single-arm, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT07180459
- Acronym / sponsor ID
- 2025-KY-1085-002
- Conditions
- Carcinoma, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Xuhua DuanUniversity, hospital or other
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 18 Sep 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.
To clarify the safety and efficacy of using uniform-sized drug-loaded embolic microspheres (E-TACE) of different particle sizes for graded embolization during TACE combined with Donafenib in the treatment of unresectable primary liver cancer. To determine whether this therapy can prolong the ORR, DCR, PFS, OS and other indicators.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-TACE in Combination with Donafenib | – | Procedure: E-TACE, Drug: Donafenib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 118 Hepatocellular carcinoma Patients
Key inclusion criteria (1 listed)
- (1) Patients with unresectable primary liver cancer who strictly meet the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines" (2024 Edition) or who have been diagnosed through pathological histology or cytology examination, and who have at least one measurable lesion (according to the mRECIST 1.1 version, the long diameter of the measurable lesion on spiral CT scan should be ≥ 10mm or the short diameter of the enlarged lymph node should be ≥ 15mm); (2) Tumor staging: CNLC stage Ib, IIa, IIb, IIIa, IIIb or BCLC A, B, C stage; non-diffuse liver cancer (PVTT classified according to the Japanese Liver Cancer Research Society's portal vein tumor thrombus characteristics as Vp1/2, Vp3, Vp4); (3) Gender of the patients is not restricted, and the age is 18-80 years old; expected lifespan is ≥ 3 months; (4) Within 1 week before enrollment, the ECOG PS score: 0-1; (5) No severe comorbidities, such as hypertension, coronary heart disease and history of mental illness, no severe allergy history; (6) Liver function should reach Child-Pugh grade A or B; (7) 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 shows urine protein < 2+; for patients whose urine protein ≥ 2+ at baseline, 24-hour urine collection should be conducted and the 24-hour urine protein quantification < 1g; international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; (8) HBV DNA < 2000 IU/ml (104 copies/ml); (9) For pregnant women of childbearing age, a pregnancy test should be conducted within 7 days before enrollment; (10) Patients have signed the informed consent form agreeing to participate in this trial study; good compliance and cooperation with treatment.
Key exclusion criteria (1 listed)
- (1) Imaging examination shows that the liver tumor is huge (≥ 60% of liver volume), or there is a main portal vein tumor thrombus (occupying the vascular diameter ≥ 50%), or the tumor thrombus invades the mesenteric vein or inferior vena cava, or there are obvious native hepatic artery - portal vein fistulas and native hepatic artery - hepatic vein fistulas that cannot safely use drug-loaded microspheres; (2) Before participating in this study, they have undergone local treatments such as traditional TACE, thermal ablation, cryoablation, external radiotherapy and radioactive particle implantation, and have received systemic chemotherapy, oral liver cancer targeted drugs (sorafenib, lenafolate, apatinib) and immune therapy (PD-1/PD-L1/CDLA-4/biologic double therapy); (3) Patients with diffuse liver cancer; known hepatocellular carcinoma and mixed cell carcinoma and fibroplastic cell carcinoma; having other untreated malignant tumors in the past (within 5 years) or simultaneously; except for cured skin basal cell carcinoma and cervical carcinoma in situ; (4) Having grade II or above myocardial ischemia or myocardial infarction, and uncontrolled arrhythmia (including QTc interval for males ≥ 450ms, females ≥ 470ms); (5) Having a history of gastrointestinal bleeding in the past 6 months or having a clear tendency for gastrointestinal bleeding, such as: esophageal varices with bleeding risk, local active ulcer lesion, fecal occult blood ≥ (++), not eligible for inclusion; if fecal occult blood (+), a gastroscopy examination is required; (6) Abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds), bleeding tendency or undergoing thrombolysis or anticoagulation treatment; (7) Patients with central nervous system metastasis or known brain metastasis; having objective evidence of past and current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of pulmonary function; patients with combined HIV infection; pregnant or lactating patients; patients preparing for liver transplantation (except for patients who have undergone liver transplantation in the past); (8) Severe systemic failure, with an expected survival period < 3 months; (9) Severe renal dysfunction (creatinine > 2mg/dl or creatinine clearance rate < 30ml/min); (10) Unable to complete the treatment plan due to various reasons, and lost follow-up within three months after enrollment.
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 |
|---|---|---|
| E-TACEThe 70/100μm drug-loaded microspheres were loaded with anthracyclines (30mg-50mg Idarubicin) at 2mL, and then combined with non-isoionic contrast agents to embolize the tumor supplying arteries, and then 250μm or 400μm drug-loaded microspheres were loaded anthracyclines (30mg-50mg Idarubicin) with 2mL/3mLto embolize the tumor supplying arteries at different grades and diameters. | Procedure or surgery | E-TACE in Combination with Donafenib |
| Donafenib400mg QD | Drug | E-TACE in Combination with Donafenib |
Primary outcome
PFS
Time frame: up to 1 year
The definition of PFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.
4 secondary outcomes
ORR
Time frame: up to 1 year
OS
Time frame: up to1 year
TTP
Time frame: up to1 year
AE
Time frame: up to1 year
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 18 Sep 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma and Hepatocellular Carcinoma, run by Xuhua Duan at 10 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 1 inclusion and 1 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Xuhua Duan Duan (+86 13523402912, xuhuaduan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 1 year). 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 18 Sep 2025.