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| Name | Class |
|---|---|
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Luoyang Central Hospital | OTHER |
| Nanyang Central Hospital | OTHER |
| Anyang Tumor Hospital |
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The purpose of this study is to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with arginine hydrochloride and trimetazidine hydrochloride tablets in the treatment of patients with hepatocellular carcinoma.
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause of cancer-related deaths in the world. Because HCC is insidious and early diagnosis is difficult, most patients have locally advanced or distant metastasis at the time of diagnosis. So they are not suitable candidates for curative treatments by resection or transplantation. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. Transarterial chemoembolization (TACE) is an important method of minimally invasive therapy in the comprehensive treatment of liver cancer. As a kind of combined treatment, it can obviously prolong the survival time of the patients. Recently, metabolomics studies of HCC have shown that typical Warburg effect was observed in hepatoma carcinoma cells. Arginine hydrochloride is a new anticancer drug in the treatment of liver cancer, which is mainly aimed at the pathway of energy metabolism. Trimetazidine hydrochloride may play an anti-tumor role by inhibiting fatty acid oxidation. The investigators have been proceeding this trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) combined with arginine hydrochloride and trimetazidine hydrochloride tablets in the treatment of patients with hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-drug Regimes | Experimental | Basic drugs therapy of HCC by TACE. |
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| Two-Drug Regimens | Experimental | Basic drugs therapy of HCC by TACE; Arginine hydrochloride |
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| Three-Drug Regimens | Experimental | Basic drugs therapy of HCC by TACE; Arginine hydrochloride;Trimetazidine hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basic drugs therapy of HCC by TACE | Device | Basic drugs include: 1. Molecular targeted drugs for HCC:apatinib; 2. Antiviral drugs (ETV or TDF) should be given to patients who were infected with HBV or HCV; 3. Patients with liver dysfunction should be treated with conventional hepatoprotective agents drugs (including glycyrrhizin, reduced glutathione, vitamin C,etc); 4. Patients with ascites symptoms should be treated with furosemide and spironolactone according to the urine volume, and they also should be treated with proton pump inhibitors in the prevention of gastrointestinal bleeding; 5. Other basic diseases were treated routinely. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Time from start of treatment until the first documented event of symptomatic progression or death. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | from start of treatment to death from any cause, or last known date of survival | 36 months |
| large vascular invasion or extrahepatic metastasis (MVI/EHV) | The effect on large vascular invasion or extrahepatic metastasis (MVI/EHV) |
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Inclusion Criteria:
1. Ages 18-65 years
2. The diagnosis of HCC: in accordance with "diagnostic and treating standards on primary liver cancer" (2011 Edition) or histological/cytological diagnosis of primary liver cancer
3. Un-resectable HCC who are eligible for TACE: patients with developing primary liver cancer of Barcelona stage(BCLC) B; multiple nodules (less than 5, the total diameter of less than 20 cm), no invasion, no symptoms; refusing open surgical treatment and volunteering for the treatment
4. There are CT or MRI measurable lesions
5. No major vascular invasion or extra hepatic metastasis
6. Child-Pugh liver function class A/B(score: ≤7)
7. Performance status 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale in one week before admission
8. Estimated survival time > 3 months
9. HBV DNA<2000 IU/ml(10^4 copies/ml); or HBV DNA≥2000 IU/ml and are accepting effective antiviral therapy
10. The major organ function is normal. that is meeting the following standards:
Blood routine examination: (No blood transfusion, no G-CSF and no medication were corrected within 14 days before screening)
a.HB≥80g/L; b.ANC≥1.5×109/L;c.PLT≥50×109/L;
Biochemical examination: (ALB was not transfused within 14 days before screening) a.ALB ≥29 g/L; b.ALT和AST<5ULN;c.TBIL ≤3ULN;d.creatinine ≤1.5ULN( albumin and bilirubin, two indicators of Child-Pugh liver function class, can only have one for 2 points)
11. For women of childbearing age, the results of serum/urine pregnancy tests must be negative within 7 days before initiation of treatment. All men and women who participate in the study have to take reliable contraceptive measures within the trial and eight weeks after the trial is completed
12. volunteers must signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zujiang Yu, Pro,Dr | Contact | 0086-0371-67966942 | johnyuem@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zujiang Yu | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
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| ID | Term |
|---|---|
| D001120 | Arginine |
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| OTHER |
| Shenma Medical Group General Hospital | OTHER |
| First People's Hospital of Shangqiu | OTHER |
| Third People's Hospital of Jiaozuo | OTHER |
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| Arginine hydrochloride | Drug | Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days. |
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| Trimetazidine hydrochloride | Drug | Trimetazidine hydrochloride, 20mg/tablet, 40mg, twice a day. |
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| 24 months |
| Disease Control Rate (DCR) | the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease | 28 days |
| Objective Response Rate(ORR) | Proportion of patients with reduction in tumor burden of a predefined amount | 28 days |
| biomarker | decrease in tumor markers | approximately 24 months |
| quality of life | The overall enjoyment of life. | approximately 36 months |
| D000601 | Amino Acids, Essential |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |