Status:
UNKNOWN
"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma
Lead Sponsor:
Yuehua Huang
Collaborating Sponsors:
Sun Yat-sen University
Nanfang Hospital, Southern Medical University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 escapin...
Detailed Description
Detailed Description Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 600 patients will be randomly assigned to experimental group and co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04317248
Start Date
April 1 2020
End Date
April 30 2022
Last Update
October 29 2020
Active Locations (4)
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1
Nanfang Hospital
Guangzhou, Guangdong, China, 510000
2
Sun Yat-sen University Cancer center
Guangzhou, Guangdong, China, 510000
3
Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
4
The Third Affiliated Hospital of Zhongshan University
Guangzhou, Guangdong, China, 510630