NCT03278444

Treatment of Advanced Hepatocellular Carcinoma

The Efficacy and Safety of Arginine Hydrochloride Combined With Trimetazidine Hydrochloride Tablets in the Treatment of Patients With Hepatocellular Carcinoma. A Multicenter, Open, Randomized, Prospective Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of arginine hydrochloride combined with trimetazidine hydrochloride tablets in the treatment of patients with hepatocellular carcinoma.

Detailed description

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. 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 arginine hydrochloride combined with trimetazidine hydrochloride tablets in the treatment of patients with hepatocellular carcinoma.

Conditions

• HCC

Interventions

Type	Name	Description
OTHER	Basic drugs therapy of HCC	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.
DRUG	Arginine hydrochloride	Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days.
DRUG	Trimetazidine hydrochloride	Trimetazidine hydrochloride tablets 20mg/tablet, 40mg, twice a day.

Timeline

• Start date: 2017-07-18
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2017-09-11
• Last updated: 2017-09-12

Locations

1 site across 1 country: China