Lenvatinib Combined Pembrolizumab in Advanced Hepatobiliary Tumors
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|ClinicalTrials.gov Identifier: NCT03895970|
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Neoplasm Malignant Primary Cholangiocarcinoma Combinational Immunotherapy Biomarker||Drug: Lenvatinib plus Pembrolizumab||Phase 2|
This trial is a single-arm, non-randomized and single-center clinical study of targeted therapy combined immunotherapy in patients with hepatobiliary malignant tumors.
It is estimated that 50 patients who met the study criteria will be enrolled in PUMCH and treated with lenvatinib and pembrolizumab. The investigators will follow up and collect subjects' data each month 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 :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients were confirmed with advanced hepatobiliary malignancies by imaging and histological examination and meet with the inclusive criteria, including hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, gallbladder carcinoma, and mixed cancer)|
|Masking:||None (Open Label)|
|Official Title:||Lenvatinib Combined Pembrolizumab as a Second-line Treatment in Advanced Hepatobiliary Tumors: a Single-center, Single-arm, Non-randomized Clinical Study|
|Actual Study Start Date :||April 20, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: Lenvatinib plus Pembrolizumab
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.
Pembrolizumab is a recombinant anti-human PD-1 monoclonal antibody.
Drug: Lenvatinib plus Pembrolizumab
Lenvatinib 12mg, once a day, oral at least 38 days of each 6 weeks cycle. Pembrolizumab 200mg, every 3 weeks, intravenous infused of each 6 weeks cycle. Number of cycle: until progression or unacceptable toxicity develops.
- Objective Response Rate (ORR) [ Time Frame: one 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: one 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: six months ]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.
- Overall Survival (OS) [ Time Frame: two years ]Duration from the date of initial treatment with lenvatinib plus pembrolizumab to the date of death due to any cause.
- Duration of Response (DOR) [ Time Frame: one year ]Duration from the first time reported partial response or complete response to the first time of disease progression or death.
- Stable Disease [ Time Frame: one year ]Proportion of patients with stable disease status more than 4 months.
- Incidence of Treatment-Emergent Adverse Event [ Time Frame: two year ]Any adverse events related with treatment with lenvatinib plus pembrolizumab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895970
|Contact: Jianzhen Linfirstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Jianzhen Lin, Doctor +86-18800158133 email@example.com|
|Contact: Xiao-Bo Yang, Doctor +86-138-1167-5126 firstname.lastname@example.org|
|Principal Investigator: Hai-Tao Zhao, Doctor|
|Study Chair:||Haitao Zhao, Prof||Peking Union Medical College Hospital (PUMCH)|