Actively Recruiting
FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial
Led by Sun Yat-sen University · Updated on 2024-01-11
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.
CONDITIONS
Official Title
FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of hepatocellular carcinoma based on EASL criteria
- At least one tumor lesion measurable by EASL standards
- Barcelona clinic liver cancer stage C
- Eastern Cooperative Oncology Group performance status of 0 to 2
- No previous treatment for hepatocellular carcinoma
- No cirrhosis or cirrhosis classified as Child-Pugh class A
- Not suitable for surgical resection, local ablative therapy, or other curative treatments
- Hepatitis B patients must receive concurrent antiviral therapy
- Laboratory values: hemoglobin 8.5 g/dL, total bilirubin 30 mmol/L, serum albumin 30 g/L, AST and ALT 5 times upper limit of normal, serum creatinine 1.5 times upper limit of normal, INR 1.5 or PT/APTT within normal limits, absolute neutrophil count over 1,500/mm3
- Ability to understand and sign informed consent
You will not qualify if you...
- Evidence of hepatic decompensation such as ascites, gastrointestinal bleeding, or hepatic encephalopathy
- Known history of HIV infection
- History of organ transplantation
- Allergy or suspected allergy to study drugs or related agents
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding disorders
- Significant gastrointestinal bleeding within 30 days before study entry
- Known central nervous system tumors, including brain metastases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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