A new clinical trial study is underway to assess the efficacy of lenvatinib and tislelizumab in combination with gemcitabine plus cisplatin (GPLET) in advanced cholangiocarcinoma (CCA). 

CCA is a heterogeneous group of malignancies resulting from the epithelial cells of bile ducts. As a result of its highly aggressive nature, most patients are diagnosed at an early stage, which makes it difficult to undergo surgery. With more effective and novel chemotherapy, targeted therapies, and immunotherapy, multiple treatments can be preferred for patients with advanced CCA.

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The death of cytotoxic cells during tumor chemotherapy causes antigen release and induces strong antitumor effects on the T cells. Tyrosine kinase inhibitors (TKIs) can reduce the PD-L1 expression and inhibit the T cell infiltration. TKIs can be combined with immune checkpoint inhibitors, and they can even relieve the tumor immunosuppressive microenvironment.

The clinical trial aims to assess the efficacy and safety of GPLET in treating advanced CCA. According to the study, 80 participants will be evaluated for a 3-year follow-up period.

Study participants must be adults or older adults who are 18 to 75 years of age and have unresectable advanced or metastatic CCA with an expected survival period of more than 12 weeks. Moreover, participants must have at least one target lesion that matches the RECIST 1.1 criteria at baseline and should have adequate organ and bone marrow function.

The exclusion criteria include history of inflammatory disease or autoimmune disease, complications that are not under control, any active infection, history of other primary malignancy, and woman going through pregnancy or breastfeeding.

The primary outcome measure of the study is reported to be the objective remission rate, while the secondary outcome measures include progression-free survival and overall survival time. The clinical trial study is expected to be completed by December 2028 and holds the potential to offer a glimmer of hope for this highly aggressive malignancy.


Lenvatinib, tislelizumab combined with Gemcitabine, and cisplatin (GPLET) in treating advanced cholangiocarcinoma. ClinicalTrials.gov. Updated April 21, 2023. Retrieved April 25, 2023