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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
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.
Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGPeking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGAffiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGThe Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGThe Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital)
Shijiazhuang, Hebei, China
RECRUITINGAnyang Tumor Hospital
Anyang, Henan, China
RECRUITINGThe First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGYichang Central People's Hospital
Yichang, Hubei, China
RECRUITINGFirst Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
RECRUITING...and 5 more locations
DCR
Target lesion disease control rate
Time frame: 30 days ± 7 days after the first TACE treatment
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.
Time frame: Immediately after the initial TACE
Objective remission rate of target lesion
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
Disease control rate of target lesions
Time frame: 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
Time frame: 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
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
the average value of the time taken for the embolization of a single lesion was calculated according to the number of embolic lesions
Time frame: Immediately after surgery
Embolization times
Record the total number of TACE treatments received by the subject from enrollment to the end of the trial
Time frame: 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
Time frame: within 1 day after surgery
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