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Tests treatment safety and results for Liver Cancer
Official title Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer
ClinicalTrials.gov ID: NCT07356531
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 1) Aged 18 to 80 (inclusive), of either gender;
- 2) people who have been diagnosed with hepatocellular carcinoma (pathologically or clinically) according to the diagnostic criteria in the "Diagnosis...
- 3) people with stage Ⅱb and Ⅲa liver cancer according to the Chinese Liver Cancer Staging Classification (CNLC), as well as people with stage Ⅰa, Ⅰb...
- 4) people with at least one untreated intrahepatic tumor lesion (maximum diameter ≤10cm) that meets the mRECIST definition (diameter ≥1cm);
- 5) The people agree to participate in this study and sign the informed consent form.
You likely can't join if
- 1) people whose target lesions have undergone local treatment (including but not limited to surgery, TACE, radiotherapy, hepatic artery infusion...
- 2) people 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...
- 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;
See the full eligibility criteria
- 1) Aged 18 to 80 (inclusive), of either gender;
- 2) people 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...
- 3) people with stage Ⅱb and Ⅲa liver cancer according to the Chinese Liver Cancer Staging Classification (CNLC), as well as people with stage Ⅰa, Ⅰb, and Ⅱa liver cancer who are not suitable/willing for surgical...
- 4) people with at least one untreated intrahepatic tumor lesion (maximum diameter ≤10cm) that meets the mRECIST definition (diameter ≥1cm);
- 5) The people agree to participate in this study and sign the informed consent form.
- 1) people whose target lesions have undergone local treatment (including but not limited to surgery, TACE, radiotherapy, hepatic artery infusion, ablation, etc.), or people whose target lesions require...
- 2) people 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 people with hypersplenism or...
- 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...
- 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...
- 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) people who have participated in other drug or medical device intervention clinical trials within 30 days before randomization;
- 16) Other people who were considered unsuitable for participation in this clinical trial by the researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Anyang, Henan, China
- Luoyang, Henan, China
- Zhengzhou, Henan, China
- Yichang, Hubei, China
- Ganzhou, Jiangxi, China
- Nanchang, Jiangxi, China
- Gongzhuling, Jilin, China
- Taiyuan, Shanxi, China
- Lishui, Zhejiang, China
- Wenzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Nanning, Guangxi, China; Guiyang, Guizhou, China; Shijiazhuang, Hebei, China; Anyang, Henan, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.