The investigators design a phase IIB clinical study to explore the efficacy and safety of Lenvatinib plus Toripalimab in patients with advanced hepatocellular carcinoma and to analyze potential biomarkers of therapeutic response.
This trial is a single-arm, non-randomized and single-center clinical study of targeted therapy combined immunotherapy in patients with hepatocellular carcinoma. It is estimated that 76 patients who met the study criteria will be enrolled in Peking Union Medical College Hospital(PUMCH) and treated with Lenvatinib and Toripalimab. The investigators will follow up and collect subjects' data monthly to evaluate the efficacy and safety of treatment, including overall survival and time to progression. Multi-omics data analysis will be used to find potential biomarkers of treatment response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Toripalimab 240mg, every 3 weeks, intravenous infused, day 1, 6 weeks a cycle. Lenvatinib 8mg (weight\<60kg) or 12mg (weight≥60kg), once a day, oral at least 38 days of each 6 weeks cycle, day 2. Number of cycle: until progression or unacceptable toxicity events develop
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective Response Rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Time frame: Up to 1 year
Disease Control Rate (DCR)
Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
Time frame: Up to 1 year
Progression-free Survival (PFS)
A duration from the date of initial treatment with lenvatinib plus pembrolizumab to disease progression (defined by RECIST 1.1) or death of any cause.
Time frame: Up to 1 years
3-months and 6-month Progression free survival rate
Portion of patients who do not experience disease progression (defined by RECIST 1.1) or death of any cause after treated with toripalimab plus lenvatinib for 3 months and 6 months, respectively.
Time frame: Up to 6 months
6-months and 1-year mortality rate
Portion of patients who die of any cause after treated with toripalimab plus lenvatinib at 6 months and 1 year, respectively.
Time frame: Up to 1 years
Duration of Response (DOR)
Duration from the first time reported partial response or complete response to the first time of disease progression or death.
Time frame: Up to 1 years
Overall Survival (OS)
Duration from the date of initial treatment with lenvatinib plus pembrolizumab to the date of death due to any cause.
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Time frame: Up to 2 years
clinical benefit rate (CBR)
Proportion of patients achieved complete response and partial response for more than 6 months.
Time frame: up to 2 years
Adverse events (AE)
Any adverse events related with treatment drugs and details include adverse events type, frequency and severity.
Time frame: up to 2 years