Liver CancerNCT07356531
Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer
A study testing Transcatheter Arterial Chemoembolization in people with Liver Cancer, run by JIANGSU SHENMING Medical Technology CO., Ltd at 15 sites in China.
Trial summary
This is a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial that will be conducted at multiple clinical trial institutions in China. The trial is divided into two phases: the lead-in phase and the main study phase, with a total of 216 subjects planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Transcatheter Arterial Chemoembolization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 15 sitesChina
- Study dates
- 29 Jul 2024to 31 May 2026
- Phase
- Interventional
- 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
Who may be able to join
- 1) Aged 18 to 80 (inclusive), of either gender;
- 2) Subjects who have been diagnosed with hepatocellular carcinoma (pathologically or clinically) according to the diagnostic criteria in the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)" and require TACE treatment;
- 3) Subjects with stage Ⅱb and Ⅲa liver cancer according to the Chinese Liver Cancer Staging Classification (CNLC), as well as subjects with stage Ⅰa, Ⅰb, and Ⅱa liver cancer who are not suitable/willing for surgical resection, liver transplantation, and ablation therapy;
- 4) Subjects with at least one untreated intrahepatic tumor lesion (maximum diameter ≤10cm) that meets the mRECIST definition (diameter ≥1cm);
- 5) The subjects agree to participate in this study and sign the informed consent form.
Who cannot join
- 1) Subjects whose target lesions have undergone local treatment (including but not limited to surgery, TACE, radiotherapy, hepatic artery infusion, ablation, etc.), or subjects whose target lesions require ablation/radiotherapy in combination with TACE treatment at the time of enrollment;
- 2) Subjects whose blood routine test results meet the following criteria: white blood cell count <3.0×10^9/L; platelet count <50×10^9/L, and this condition cannot be corrected (excluding subjects with hypersplenism or chemotherapy-induced bone marrow suppression);
- 3) Renal dysfunction: serum creatinine >176.8 μmol/L or creatinine clearance rate < 30 ml/min;
- 4) Uncorrectable coagulation dysfunction;
- 5) Uncorrectable hypercalcemia and respiratory acidosis;
- 6) Patients with systemic cachexia or multiple organ failure;
Show all 16Show fewer
- 7) Patients with severe infections that cannot be effectively controlled and are not suitable for TACE treatment;
- 8) Complete obstruction of the main portal vein, insufficient collateral compensation of the portal vein, and inability to restore portal venous blood flow to the liver through portal veinoplasty;
- 9) Known contraindications or allergies to anthracycline chemotherapeutic drugs, calcium chloride injection, contrast media, and embolic materials;
- 10) Patients who are currently using cardiac glycosides;
- 11) Patients with target lesions who are at risk of ectopic embolism in the feeding artery (such as vascular access endangering normal areas, uncorrectable arteriovenous fistulas, and portal vein fistulas) or anatomical abnormalities that make them unsuitable for interventional procedures;
- 12) Patients who have been diagnosed with other malignant tumors within 2 years before randomization (except for basal cell or squamous cell skin cancer, cervical or breast carcinoma in situ that have been resected radically);
- 13) Patients with diffuse or distant extensive metastasis of tumors, with an expected survival time of less than 90 days;
- 14) Pregnant/lactating women, or those who have family planning;
- 15) Subjects who have participated in other drug or medical device intervention clinical trials within 30 days before randomization;
- 16) Other subjects who were considered unsuitable for participation in this clinical trial by the researchers.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Anyang Tumor Hospital
Anyang, Henan, 455001
Qiuliang Wei, chief physician, +86 13598138873, weiqiuliang888@sina.com
Qiuliang Wei, chief physician
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yinghua Zou, chief physician, +86 13801105222, 13801105222@139.com
Yinghua Zou, chief physician
- Recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341099
Xiao He, chief physician, +86 13970111860, Hexiao00914@aliyun.com
Xiao He, chief physician
- Recruiting
Jilin Guowen Hospital
Gongzhuling, Jilin, 130028
Chuanwei Hou, associate chief physician, +86 13159578526, h13159578526@163.com
Chuanwei Hou, associate chief physician
- Recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550008
Wei He, associate chief physician, +86 13608537377, 1079570343@qq.com
Wei He, associate chief physician
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230002
Weifu Lv, chief physician, +8618909694640, lwf99@126.com
Weifu Lv, chief physician
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang, 323020
Jiansong Ji, chief physician, +86 13757862930, jjstcty@sina.com
Jiansong Ji, chief physician
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471023
Huanzhang Niu, chief physician, +86 18939009358, niuhuanzhang@126.com
Huanzhang Niu, chief physician
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Fan Zhou, associate chief physician, +86 18879138800, nczhoufan@126.com
Fan Zhou, associate chief physician
- Recruiting
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, 530012
Chang Zhao, associate chief physician, +86 13768372540, 710519137@qq.com
Chang Zhao, associate chief physician
- Recruiting
The Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital)
Shijiazhuang, Hebei, '050010
Guang Yang, chief physician, +86 18531116187, yanggzj@163.com
Guang Yang, chief physician
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, '030032
Wendong Cao, chief physician, +86 18636188999, Caowd67@sina.com
Wendong Cao, chief physician
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Chang Yu, associate chief physician, +86 13639075380, wzmcyc@126.com
chang Yu, associate chief physician
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443008
Cui Chen, chief physician, +86 13972003797, 79146460@qq.com
Cui Chen, chief physician
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Hongtao Hu, chief physician, + 8613592616373, 13592616373@163.com
Hongtao Hu, chief physician
About this study
This is a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial that will be conducted at multiple clinical trial institutions in China. The trial is divided into two phases: the lead-in phase and the main study phase, with a total of 216 subjects planned to be enrolled. In the main study phase, subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group. The randomly assigned subjects will receive TACE treatment. The test group will receive embolization therapy with anthracycline chemotherapy drugs, iodinated oil, and tumor temperature-sensitive embolic agents (test group), while the control group will receive embolization therapy with anthracycline chemotherapy drugs, iodinated oil, and gelatin sponge particles (control group).
Read the detailed description
The purpose of this study is to evaluate the safety and effectiveness of the tumor thermosensitive he main efficacy evaluation indicator of this clinical trial is disease control rate. This indicator is widely regarded as a reflection of the effectiveness of tumor treatment, indicating the proportion of tumors that completely disappear, shrink, or remain stable after TACE treatment. Analyzing the results of the subjects, indirectly and directly reflecting clinical benefits, is preliminary reliable evidence of anti-tumor activity in treatment. As the main purpose of this experiment is to evaluate the tumor response of liver tumors treated with TACE using tumor thermosensitive embolic agents and compare it with gelatin sponge embolic agents,
- Conditions
- Liver Cancer
- Being tested
- Transcatheter Arterial Chemoembolization
- Keywords
- thermosensitive embolic agent
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial ChemoembolizationDevice
Also called Tace
In the main research stage, the researchers randomly confirmed the subject groups, and the experimental group used anthracycline chemotherapy drugs, iodized oil, and tumor thermosensitive embolization agents for embolization; The control group was treated with anthracycline chemotherapy drugs, iodized oil, and gelatin sponge particles embolization for embolization.
| Study group | Role | What they receive |
|---|---|---|
| Tumor thermosensitive embolic agent | Experimental | The experimental group received anthracycline chemotherapy drugs, iodinated oil, and tumor thermosensitive embolic agents。 Receives: Device: Transcatheter Arterial Chemoembolization |
| Gelatin sponge granules embolic agent | Active comparator | The control group received anthracycline chemotherapy drugs, iodinated oil, and gelatin sponge particle embolic agents Receives: Device: Transcatheter Arterial Chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCR
Target lesion disease control rate
Measured: 30 days ± 7 days after the first TACE treatment
Secondary outcomes (8)
Immediate success rate of target lesion embolization
The immediate success rate of target lesion embolization refers to the percentage of successful embolization cases in the total number of cases immediately after the initial TACE angiography review.
Measured: Immediately after the initial TACE
Objective remission rate of target lesion
Objective remission rate of target lesion
Measured: 30 days ± 7 days after the first TACE treatment, 30 days ± 7 days, 90 days ± 15 days and 180 days ± 30 days after the last TACE treatment
DCR
Disease control rate of target lesions
Measured: 30 days, 90 days and 180 days after the last TACE treatment
Duration of target lesion response
The duration of target lesion response refers to the time from the initial recording to the target lesion CR or PR to the target lesion PD or death
Measured: 30 days after the first TACE treatment, 30 days, 90 days, and 180 days after the last TACE treatment
AFP
Changes of serum alpha fetoprotein values
Measured: 30 days ± 7 days after the first TACE treatment, 30 days ± 7 days, 90 days ± 15 days and 180 days ± 30 days after the last TACE treatment
Duration of embolization
the average value of the time taken for the embolization of a single lesion was calculated according to the number of embolic lesions
Measured: Immediately after surgery
Embolization times
Record the total number of TACE treatments received by the subject from enrollment to the end of the trial
Measured: Within 90 days after surgery
Device performance evaluation
The surgeon conducted a subjective evaluation of the performance of the trial device during the surgical process after the operation, including system infusion performance, embolization performance, imaging performance, and overall evaluation, using a grading system of "excellent", "good", "fair", "acceptable", and "poor" to complete the evaluation
Measured: within 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start29 Jul 2024
- Primary completion14 Nov 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Model description
- This trial is a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial.
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JIANGSU SHENMING Medical Technology CO., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356531
- Sponsor's protocol ID
- SM-WMSSJ-001
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT07356531
- Acronym / sponsor ID
- SM-WMSSJ-001
- Conditions
- Liver Cancer
- Keywords
- thermosensitive embolic agent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- JIANGSU SHENMING Medical Technology CO., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 14 Nov 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Jan 2026 (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, multicenter, randomized, parallel-controlled, non-inferiority clinical trial that will be conducted at multiple clinical trial institutions in China. The trial is divided into two phases: the lead-in phase and the main study phase, with a total of 216 subjects planned to be enrolled. In the main study phase, subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group. The randomly assigned subjects will receive TACE treatment. The test group will receive embolization therapy with anthracycline chemotherapy drugs, iodinated oil, and tumor temperature-sensitive embolic agents (test group), while the control group will receive embolization therapy with anthracycline chemotherapy drugs, iodinated oil, and gelatin sponge particles (control group).
Detailed description
The purpose of this study is to evaluate the safety and effectiveness of the tumor thermosensitive he main efficacy evaluation indicator of this clinical trial is disease control rate. This indicator is widely regarded as a reflection of the effectiveness of tumor treatment, indicating the proportion of tumors that completely disappear, shrink, or remain stable after TACE treatment. Analyzing the results of the subjects, indirectly and directly reflecting clinical benefits, is preliminary reliable evidence of anti-tumor activity in treatment. As the main purpose of this experiment is to evaluate the tumor response of liver tumors treated with TACE using tumor thermosensitive embolic agents and compare it with gelatin sponge embolic agents,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial is a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Tumor thermosensitive embolic agent | Experimental | Device: Transcatheter Arterial ChemoembolizationThe experimental group received anthracycline chemotherapy drugs, iodinated oil, and tumor thermosensitive embolic agents。 |
| Gelatin sponge granules embolic agent | Active comparator | Device: Transcatheter Arterial ChemoembolizationThe control group received anthracycline chemotherapy drugs, iodinated oil, and gelatin sponge particle embolic agents |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Aged 18 to 80 (inclusive), of either gender;
- 2) Subjects who have been diagnosed with hepatocellular carcinoma (pathologically or clinically) according to the diagnostic criteria in the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition)" and require TACE treatment;
- 3) Subjects with stage Ⅱb and Ⅲa liver cancer according to the Chinese Liver Cancer Staging Classification (CNLC), as well as subjects with stage Ⅰa, Ⅰb, and Ⅱa liver cancer who are not suitable/willing for surgical resection, liver transplantation, and ablation therapy;
- 4) Subjects with at least one untreated intrahepatic tumor lesion (maximum diameter ≤10cm) that meets the mRECIST definition (diameter ≥1cm);
- 5) The subjects agree to participate in this study and sign the informed consent form.
Key exclusion criteria (16 listed)
- 1) Subjects whose target lesions have undergone local treatment (including but not limited to surgery, TACE, radiotherapy, hepatic artery infusion, ablation, etc.), or subjects whose target lesions require ablation/radiotherapy in combination with TACE treatment at the time of enrollment;
- 2) Subjects whose blood routine test results meet the following criteria: white blood cell count <3.0×10^9/L; platelet count <50×10^9/L, and this condition cannot be corrected (excluding subjects with hypersplenism or chemotherapy-induced bone marrow suppression);
- 3) Renal dysfunction: serum creatinine >176.8 μmol/L or creatinine clearance rate < 30 ml/min;
- 4) Uncorrectable coagulation dysfunction;
- 5) Uncorrectable hypercalcemia and respiratory acidosis;
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 |
|---|---|---|
| Transcatheter Arterial ChemoembolizationAlso: TaceIn the main research stage, the researchers randomly confirmed the subject groups, and the experimental group used anthracycline chemotherapy drugs, iodized oil, and tumor thermosensitive embolization agents for embolization; The control group was treated with anthracycline chemotherapy drugs, iodized oil, and gelatin sponge particles embolization for embolization. | Device | Gelatin sponge granules embolic agent, Tumor thermosensitive embolic agent |
Primary outcome
DCR
Time frame: 30 days ± 7 days after the first TACE treatment
Target lesion disease control rate
8 secondary outcomes
Immediate success rate of target lesion embolization
Time frame: Immediately after the initial TACE
Objective remission rate of target lesion
Time frame: 30 days ± 7 days after the first TACE treatment, 30 days ± 7 days, 90 days ± 15 days and 180 days ± 30 days after the last TACE treatment
DCR
Time frame: 30 days, 90 days and 180 days after the last TACE treatment
Duration of target lesion response
Time frame: 30 days after the first TACE treatment, 30 days, 90 days, and 180 days after the last TACE treatment
AFP
Time frame: 30 days ± 7 days after the first TACE treatment, 30 days ± 7 days, 90 days ± 15 days and 180 days ± 30 days after the last TACE treatment
Duration of embolization
Time frame: Immediately after surgery
Embolization times
Time frame: Within 90 days after surgery
Device performance evaluation
Time frame: within 1 day after surgery
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 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Liver Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Arterial Chemoembolization in people with Liver Cancer, run by JIANGSU SHENMING Medical Technology CO., Ltd at 15 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 16 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 Huamin Wang (+86 15116996413, huaminwang@grandpharma.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCR (time frame: 30 days ± 7 days after the first TACE treatment). 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 21 Jan 2026.