NCT03950518

Novel Treatment of Advanced Hepatocellular Carcinoma

Multicenter, Randomized, Open, Parallel, Prospective, Exploratory Clinical Study of Arginine Hydrochloride and Levamisole in the Treatment of Advanced HCC

• 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 Levamisole 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, There are only not more than five drugs to be selected 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 HCC, which is mainly aimed at the pathway of energy metabolism. levamisole may play an anti-tumor role by inhibiting the reverse TCA cycle. The investigators have been proceeding this trial to evaluate the efficacy and safety of arginine hydrochloride combined with levamisole in the treatment of patients with advanced hepatocellular carcinoma.

Conditions

• HCC

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride Capsules	Anlotinib Hydrochloride Capsules, 12mg/d
DRUG	Arginine hydrochloride	AHC,12mg/d AH,40g/d
DRUG	levamisole	AHC,12mg/d AH,40mg/d LM,150mg/d

Timeline

• Start date: 2019-04-10
• Primary completion: 2023-04-10
• Completion: 2023-04-10
• First posted: 2019-05-15
• Last updated: 2019-05-15

Locations

1 site across 1 country: China