NCT07356531

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jul 2024May 2026

Study Start

First participant enrolled

July 29, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

November 26, 2025

Last Update Submit

January 12, 2026

Conditions

Liver Cancer

Keywords

thermosensitive embolic agent

Outcome Measures

Primary Outcomes (1)

  • DCR

    Target lesion disease control rate

    30 days ± 7 days after the first TACE treatment

Secondary Outcomes (8)

  • Immediate success rate of target lesion embolization

    Immediately after the initial TACE

  • 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

    30 days, 90 days and 180 days after the last TACE treatment

  • Duration of target lesion response

    30 days after the first TACE treatment, 30 days, 90 days, and 180 days after the last TACE treatment

  • AFP

    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

  • +3 more secondary outcomes

Study Arms (2)

Tumor thermosensitive embolic agent

EXPERIMENTAL

The experimental group received anthracycline chemotherapy drugs, iodinated oil, and tumor thermosensitive embolic agents。

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

Device: Transcatheter Arterial Chemoembolization

Interventions

Transcatheter Arterial ChemoembolizationDEVICE

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.

Also known as: Tace
Gelatin sponge granules embolic agentTumor thermosensitive embolic agent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) Aged 18 to 80 (inclusive), of either gender;
  • \) 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;
  • \) 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;
  • \) Subjects with at least one untreated intrahepatic tumor lesion (maximum diameter ≤10cm) that meets the mRECIST definition (diameter ≥1cm);
  • \) The subjects agree to participate in this study and sign the informed consent form.

You may not qualify if:

  • \) 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;
  • \) 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);
  • \) Renal dysfunction: serum creatinine \>176.8 μmol/L or creatinine clearance rate \< 30 ml/min;
  • \) Uncorrectable coagulation dysfunction;
  • \) Uncorrectable hypercalcemia and respiratory acidosis;
  • \) Patients with systemic cachexia or multiple organ failure;
  • \) Patients with severe infections that cannot be effectively controlled and are not suitable for TACE treatment;
  • \) 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;
  • \) Known contraindications or allergies to anthracycline chemotherapeutic drugs, calcium chloride injection, contrast media, and embolic materials;
  • \) Patients who are currently using cardiac glycosides;
  • \) 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;
  • \) 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);
  • \) Patients with diffuse or distant extensive metastasis of tumors, with an expected survival time of less than 90 days;
  • \) Pregnant/lactating women, or those who have family planning;
  • \) Subjects who have participated in other drug or medical device intervention clinical trials within 30 days before randomization;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Anhui Provincial Hospital

Hefei, Anhui, 230002, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, 530012, China

RECRUITING

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550008, China

RECRUITING

The Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital)

Shijiazhuang, Hebei, '050010, China

RECRUITING

Anyang Tumor Hospital

Anyang, Henan, 455001, China

RECRUITING

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, 471023, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Yichang Central People's Hospital

Yichang, Hubei, 443008, China

RECRUITING

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341099, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

RECRUITING

Jilin Guowen Hospital

Gongzhuling, Jilin, 130028, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, '030032, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, 323020, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver Diseases

Central Study Contacts

Huamin Wang

CONTACT

+86 15116996413huaminwang@grandpharma.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open Label
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This trial is a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2025

First Posted

January 21, 2026

Study Start

July 29, 2024

Primary Completion

November 14, 2025

Study Completion (Estimated)

May 31, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

CN(15)