Biliary intervention combined with lenvatinib+ PD-1 inhibitor of Klatskin tumor complicated with malignant obstructive jaundice.

Abstract

e14620 Background: Hilar Cholangiocarcinoma (Klatskin tumor) is a rare and highly aggressive cancer that occurs at or near the junction of the right and left hepatic ducts. Gemcitabine + cisplatin has been established as an effective first-line treatment. However, this malignancy is commonly complicated by malignant biliary obstruction which may gradually damage patients’ liver function and may limit the chemotherapy. In addition, Cumulative clinical evidence showed that tyrosine kinase inhibitor (TKI) combined with immunotherapy is represented as a promising alternative. This study aimed to evaluate the clinical value of biliary intervention combined with the Lenvatinib+PD-1 inhibitor (Tislelizumab/Sintilimab) for the Klatskin tumor. Methods: From January 2020 to December 2022, 21 Klatskin tumor patients with malignant hilar biliary obstruction (MHBO) were included. All included patients received biliary decompression by metal stent + Iodine-125 seed strand (ISS) implantation. The number of 125I seeds to be implanted was determined according to the plan of the preoperative computerized treatment planning system (TPS). The procedure-related outcomes were evaluated regarding successful drainage and complications. In addition, the survival of patients who received successful biliary drainage and patients who received sequential systemic anticancer treatment were analyzed. Successful biliary drainage was defined as the serum total bilirubin level dropped by 75% of the preoperative value within 4 weeks. Major complications referred to those that result in death or serious adverse effects including sepsis, uncontrollable biliary or intestinal bleeding, and acute renal failure. The time between stent insertion and death was defined as patient survival. Results: 71.4% achieved successful drainage, significant improvements were observed from before to one month after the procedure in liver function values, including total bilirubin (TBIL), and direct bilirubin (DBIL) (all P<0.001). Minor complications occurred in 5 patients (23.8%) in all patients, including 1 patient (4.8%) who experienced cholangitis, and 4 patients (19%) who suffered abdominal pain. No major procedure-related complication was observed. The median overall survival(mOS) of 21 patients was 6.1 months. Patients who received successful biliary drainage (n=15) had longer mOS than those who received unsuccessful biliary drainage(n=6) [7.4 months vs. 3.5 months, respectively, P<0.001]. Patients who received sequential Lenvatinib+ Pembrolizumab after effective drainage(n=9) had longer mOS than those who only received palliative therapy(n=6) [7.4 months vs. 5.2 months, respectively, P=0.028]. Conclusions: Biliary intervention + ISS combined with the following Lenvatinib+ PD-1 inhibitor is safe and feasible for cholangiocarcinoma patients complicated with obstructive jaundice.