"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer cells escaping from immune surveillance and constructs an immunosuppressive microenvironment. Correspondingly, multiple signals loaded dendritic cells vaccine can efficiently present T cells with antigens of HCC sensitize their antitumor properties meanwhile low dose cyclophosphamide (CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "multiple signals loaded dendritic cells vaccine combined low dose of cyclophosphamide" combining with radical surgery or TACE or targeted agents for patients with hepatocellular carcinoma to prolong their survival time.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuehua Huang
• Collaborators: Nanfang Hospital of Southern Medical University; Sun Yat-sen University
• Treatments: Cyclophosphamide; Vaccines

Criteria

Inclusion Criteria:

• In accordance with AASLD guidelines for the diagnosis of hepatocellular carcinoma，histology or imaging confirmed as primary hepatocellular carcinoma

• Patients with history of hepatitis B infection

• Male and female adult subjects (18～70 years old)

• Patients haven't received radiation therapy or chemotherapy or immunotherapy

• Normal renal function

• Blood routine test: Hb>=9g/dL, white cell count>=1.5*10^9/L, platelet count>=50*10^9/L

• Liver function: bilirubin<=50umol/L, aspartate aminotransferase (AST) or alanine aminotransferase(ALT)<=5 times the upper limit of normal

• Child-Pugh score<=9

• Human Chorionic Gonadotropin(HCG) test negative(-) if patients are women of reproductive ages

• Women of reproductive ages promise to contracept until therapy course has been finished for 3 months

• Patients who have signed up informed consents

Exclusion Criteria:

• Extrahepatic metastasis of hepatocellular carcinoma oHistory of embolism, chemotherapy or radiation

• History of major surgery in last 4 weeks

• History of radiofrequency ablation in last 6 weeks

• Acute infections in last 2 weeks

• Child-Pugh scores>9

• Patients with hepatic encephalopathy

• Patients with ascites needed drainage

• Patients have history of other cancer

• Patients have history of HIV

• Pregnant women

• Patients with severe diseases like cardiac dysfunction

• Patients with mental illness that influence signing informed consents

• HBV infection combined with other types of hepatitis

• Patients with autoimmune diseases

• Immunosuppressant drugs users

• Patients cannot follow our trial principle