Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer

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).

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Device: Transcatheter Arterial Chemoembolization

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 Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huamin Wang; Phone Number: +86 15116996413; Email: huaminwang@grandpharma.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230002
      • Recruiting
      • Anhui Provincial Hospital
      • Contact: Weifu Lv, chief physician; Phone Number: +8618909694640; Email: lwf99@126.com
      • Principal Investigator: Weifu Lv, chief physician
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Yinghua Zou, chief physician; Phone Number: +86 13801105222; Email: 13801105222@139.com
      • Principal Investigator: Yinghua Zou, chief physician
  • Guangxi
    • Nanning, Guangxi, China, 530012
      • Recruiting
      • Affiliated Cancer Hospital of Guangxi Medical University
      • Contact: Chang Zhao, associate chief physician; Phone Number: +86 13768372540; Email: 710519137@qq.com
      • Principal Investigator: Chang Zhao, associate chief physician
  • Guizhou
    • Guiyang, Guizhou, China, 550008
      • Recruiting
      • The Affiliated Cancer Hospital of Guizhou Medical University
      • Contact: Wei He, associate chief physician; Phone Number: +86 13608537377; Email: 1079570343@qq.com
      • Principal Investigator: Wei He, associate chief physician
  • Hebei
    • Shijiazhuang, Hebei, China, '050010
      • Recruiting
      • The Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital)
      • Contact: Guang Yang, chief physician; Phone Number: +86 18531116187; Email: yanggzj@163.com
      • Principal Investigator: Guang Yang, chief physician
  • Henan
    • Anyang, Henan, China, 455001
      • Recruiting
      • AnYang Tumor Hospital
      • Contact: Qiuliang Wei, chief physician; Phone Number: +86 13598138873; Email: weiqiuliang888@sina.com
      • Principal Investigator: Qiuliang Wei, chief physician
    • Luoyang, Henan, China, 471023
      • Recruiting
      • The First Affiliated Hospital of Henan University of Science & Technology
      • Contact: Huanzhang Niu, chief physician; Phone Number: +86 18939009358; Email: niuhuanzhang@126.com
      • Principal Investigator: Huanzhang Niu, chief physician
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Hongtao Hu, chief physician; Phone Number: + 8613592616373; Email: 13592616373@163.com
      • Principal Investigator: Hongtao Hu, chief physician
  • Hubei
    • Yichang, Hubei, China, 443008
      • Recruiting
      • Yichang Central People's Hospital
      • Contact: Cui Chen, chief physician; Phone Number: +86 13972003797; Email: 79146460@qq.com
      • Principal Investigator: Cui Chen, chief physician
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341099
      • Recruiting
      • First Affiliated Hospital of Gannan Medical University
      • Contact: Xiao He, chief physician; Phone Number: +86 13970111860; Email: Hexiao00914@aliyun.com
      • Principal Investigator: Xiao He, chief physician
    • Nanchang, Jiangxi, China, 330008
      • Recruiting
      • The Second Affiliated Hospital of Nanchang University
      • Contact: Fan Zhou, associate chief physician; Phone Number: +86 18879138800; Email: nczhoufan@126.com
      • Principal Investigator: Fan Zhou, associate chief physician
  • Jilin
    • Gongzhuling, Jilin, China, 130028
      • Recruiting
      • Jilin Guowen Hospital
      • Contact: Chuanwei Hou, associate chief physician; Phone Number: +86 13159578526; Email: h13159578526@163.com
      • Principal Investigator: Chuanwei Hou, associate chief physician
  • Shanxi
    • Taiyuan, Shanxi, China, '030032
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: Wendong Cao, chief physician; Phone Number: +86 18636188999; Email: Caowd67@sina.com
      • Principal Investigator: Wendong Cao, chief physician
  • Zhejiang
    • Lishui, Zhejiang, China, 323020
      • Recruiting
      • Lishui Central Hospital
      • Contact: Jiansong Ji, chief physician; Phone Number: +86 13757862930; Email: jjstcty@sina.com
      • Principal Investigator: Jiansong Ji, chief physician
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Chang Yu, associate chief physician; Phone Number: +86 13639075380; Email: wzmcyc@126.com
      • Principal Investigator: chang Yu, associate chief physician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumor thermosensitive embolic agent; The experimental group received anthracycline chemotherapy drugs, iodinated oil, and tumor thermosensitive embolic agents。	Device: Transcatheter Arterial Chemoembolization; 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.; Other Names: Tace
Active Comparator: Gelatin sponge granules embolic agent; The control group received anthracycline chemotherapy drugs, iodinated oil, and gelatin sponge particle embolic agents	Device: Transcatheter Arterial Chemoembolization; 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.; Other Names: Tace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCR	Target lesion disease control rate	30 days ± 7 days after the first TACE treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the initial TACE
Objective remission rate of target lesion	Objective remission rate of target lesion	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	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	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	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	Immediately after surgery
Embolization times	Record the total number of TACE treatments received by the subject from enrollment to the end of the trial	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	within 1 day after surgery

Collaborators and Investigators

• Sponsor: JIANGSU SHENMING Medical Technology CO., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2024
• Primary Completion (Actual): November 14, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: thermosensitive embolic agent
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: SM-WMSSJ-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No