Evaluating triple therapy with lenvatinib, PD-1 inhibitor and transarterial chemoembolization for unresectable intrahepatic cholangiocarcinoma: A retrospective study.

e16210 Background: Cholangiocarcinoma has a poor prognosis and responds poorly to intravenous chemotherapy. This study evaluated the efficacy and safety of a triple therapy combining transarterial chemoembolization (TACE) with lenvatinib and programmed cell death protein (PD)-1 inhibitors for treating unresectable intrahepatic cholangiocarcinoma (ICCA). Methods: This retrospective study included a total of 15 patients with unresectable ICCA who were initially treated with TACE. One week later, they received lenvatinib 8 mg/day orally and PD-1 inhibitors for 21 days/cycle. The primary endpoint was the objective response rate (ORR); secondary endpoints included disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and the incidence of treatment-related adverse events (TRAEs). Results: At 1-month post-treatment, the ORR was 73.3% and the DCR was 86.7%. The median PFS was 10.4 months (95% confidence interval [CI]: 6.73, not reached), and the median OS was 16.9 months (95% CI: 9.2, not reached). Compared with pre-treatment data, post-treatment levels of the tumor serum markers carcinoembryonic antigen and carbohydrate antigen 19-9 had decreased significantly (P<0.05). However, 13 patients experienced Grade 1–2 TRAEs, including decreased appetite (n=8 [53.3%]), fatigue (n=3 [20.0%]), weight-loss (n=3 [20.0%]), hypertension (n=2 [13.3%]), hand–foot syndrome (n=2 [13.3%]), diarrhea (n=1 [6.7%]), dysphonia (n=1 [6.7%]), and hypothyroidism (n=1 [6.7%]). No patient experienced Grade ≥3 TRAEs during treatment or follow-up. Conclusions: Triple therapy with TACE, lenvatinib and PD-1 inhibitors showed promising antitumor activity as well as a tolerable safety profile in patients with ICCA. Larger clinical studies investigating this treatment combination should be considered.