Actively Recruiting
Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer
Led by JIANGSU SHENMING Medical Technology CO., Ltd · Updated on 2026-01-21
216
Participants Needed
15
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years, any gender
- Diagnosed with hepatocellular carcinoma according to 2024 Chinese guidelines and requiring TACE treatment
- Liver cancer stage Ib or IIa by Chinese Liver Cancer Staging, or stages 0a, 0b, or Ia unsuitable or unwilling for surgery, transplantation, or ablation
- At least one untreated intrahepatic tumor lesion measuring 1 cm or larger and no more than 10 cm
- Agree to participate and sign informed consent
You will not qualify if you...
- Target lesions previously treated by surgery, TACE, radiotherapy, hepatic artery infusion, ablation, or requiring combined ablation/radiotherapy at enrollment
- White blood cell count below 3.0 x 10^9/L or platelet count below 50 x 10^9/L not correctable
- Renal dysfunction: serum creatinine above 176.8 µmol/L or creatinine clearance below 30 ml/min
- Uncorrectable coagulation dysfunction
- Uncorrectable hypercalcemia or respiratory acidosis
- Systemic cachexia or multiple organ failure
- Severe uncontrolled infections unsuitable for TACE
- Complete main portal vein obstruction with insufficient collateral compensation
- Known allergies to anthracycline drugs, calcium chloride injection, contrast media, or embolic materials
- Current use of cardiac glycosides
- Risk of ectopic embolism or anatomical abnormalities making interventional procedures unsuitable
- Other malignant tumors diagnosed within 2 years except certain skin or carcinoma in situ cancers
- Diffuse or distant metastases with expected survival under 90 days
- Pregnant or lactating women or those with family planning
- Participation in other drug or device trials within 30 days before randomization
- Any other condition making participation unsuitable per investigators
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230002
Actively Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
3
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530012
Actively Recruiting
4
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550008
Actively Recruiting
5
The Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital)
Shijiazhuang, Hebei, China, '050010
Actively Recruiting
6
Anyang Tumor Hospital
Anyang, Henan, China, 455001
Actively Recruiting
7
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471023
Actively Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
9
Yichang Central People's Hospital
Yichang, Hubei, China, 443008
Actively Recruiting
10
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China, 341099
Actively Recruiting
11
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330008
Actively Recruiting
12
Jilin Guowen Hospital
Gongzhuling, Jilin, China, 130028
Actively Recruiting
13
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, '030032
Actively Recruiting
14
Lishui Central Hospital
Lishui, Zhejiang, China, 323020
Actively Recruiting
15
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
H
Huamin Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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