Temperature-sensitive embolic agent during chemoembolization for primary liver cancer

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

This trial will see if adding a temperature-sensitive embolic agent to TACE controls liver tumors as well as standard gelatin sponge particles in adults with primary liver cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: GrandPharma (China) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 15 sites (Hefei, Anhui and 14 other locations)
• Trial ID: NCT07356531 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, randomized, parallel-controlled, non-inferiority trial in China with a lead-in phase followed by a main study enrolling about 216 subjects. Participants are randomly assigned 1:1 to receive transcatheter arterial chemoembolization (TACE) with anthracycline and iodized oil combined with either a temperature-sensitive tumor embolic agent (test) or gelatin sponge particles (control). The main efficacy endpoint is disease control rate by mRECIST, capturing complete responses, partial responses, and stable disease. Safety and tumor response will be compared between groups to determine whether the thermosensitive agent performs at least as well as the standard embolic material.

Who should consider this trial

Good fit: Adults 18–80 with hepatocellular carcinoma meeting CNLC stage IIb–IIIa or earlier-stage patients who are not candidates for resection, transplantation, or ablation and who have at least one untreated intrahepatic lesion ≥1 cm are appropriate candidates.

Not a fit: Patients whose target lesions have already received local treatment, those with lesions exceeding the protocol size limits, or those with medical conditions that make TACE inappropriate (for example, very poor liver function or extensive extrahepatic disease) are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the temperature-sensitive embolic agent could improve local tumor control after TACE and potentially reduce recurrence compared with standard gelatin sponge particles.

How similar studies have performed: Temperature-sensitive embolic agents are a relatively new approach with limited clinical data, while conventional embolic materials such as gelatin sponge have established use and supporting evidence in TACE.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 14 other locations

• Anhui Provincial Hospital — Hefei, Anhui, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Affiliated Cancer Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
• The Affiliated Cancer Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)
• The Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital) — Shijiazhuang, Hebei, China (Recruiting)
• Anyang Tumor Hospital — Anyang, Henan, China (Recruiting)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Yichang Central People's Hospital — Yichang, Hubei, China (Recruiting)
• First Affiliated Hospital of Gannan Medical University — Ganzhou, Jiangxi, China (Recruiting)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• Jilin Guowen Hospital — Gongzhuling, Jilin, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• Lishui Central Hospital — Lishui, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Huamin Wang

Conditions Liver Cancer; thermosensitive embolic agent