Lenvatinib Combined Toripalimab in Advanced Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT04368078|
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : October 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Toripalimab plus Lenvatinib||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lenvatinib Combined Toripalimab in Advanced Hepatocellular Carcinoma: a Single-center, Single-arm, Non-randomized Clinical Study|
|Estimated Study Start Date :||October 11, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2023|
Experimental: Toripalimab plus Lenvatinib
Lenvatinib is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.
Toripalimab is a recombinant anti-human PD-1 monoclonal antibody.
Drug: Toripalimab plus Lenvatinib
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
Other Name: JS001 plus E7080
- Objective Response Rate (ORR) [ Time Frame: Up to 1 year ]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.
- Disease Control Rate (DCR) [ Time Frame: Up to 1 year ]Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
- Progression-free Survival (PFS) [ Time Frame: Up to 1 years ]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.
- 3-months and 6-month Progression free survival rate [ Time Frame: Up to 6 months ]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.
- 6-months and 1-year mortality rate [ Time Frame: Up to 1 years ]Portion of patients who die of any cause after treated with toripalimab plus lenvatinib at 6 months and 1 year, respectively.
- Duration of Response (DOR) [ Time Frame: Up to 1 years ]Duration from the first time reported partial response or complete response to the first time of disease progression or death.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]Duration from the date of initial treatment with lenvatinib plus pembrolizumab to the date of death due to any cause.
- clinical benefit rate (CBR) [ Time Frame: up to 2 years ]Proportion of patients achieved complete response and partial response for more than 6 months.
- Adverse events (AE) [ Time Frame: up to 2 years ]Any adverse events related with treatment drugs and details include adverse events type, frequency and severity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368078
|Contact: Xiaobo Yang, firstname.lastname@example.org|
|Contact: Xu Yang, email@example.com|
|Principal Investigator:||Haitao Zhao, MD||Peking Union Medical College Hospital|