ABSTRACT Background Biliary tract cancer (BTC) is an aggressive malignancy characterized by a high recurrence rate and poor postoperative prognosis, despite advances in adjuvant therapy. This phase II study evaluated the efficacy and safety of a novel adjuvant regimen combining envafolimab, lenvatinib, and capecitabine in patients with BTC at high risk of recurrence following R0 resection. Methods This single‐center, open‐label, single‐arm phase II trial enrolled patients with high‐risk recurrence factors after curative resection. Patients received envafolimab (400 mg subcutaneously once every 3 weeks), Lenvatinib (8 mg orally once daily), and capecitabine (1000 mg/m 2 orally twice daily, 2 weeks on/1 week off, continued without cycle limitation). The primary endpoint was disease‐free survival (DFS); secondary endpoints included overall survival (OS) and safety. Results 28 of 30 screened patients were included in the final analysis. The median DFS was 15.63 months, and the 1‐year DFS rate was 68.3%. Median OS was not reached but 1‐year OS was 91.4%. Treatment‐related adverse events (TRAEs) occurred in 17 patients, with grade 3/4 TRAEs observed in eight patients. No treatment‐related deaths were reported. Exploratory analysis suggested that baseline CA19‐9 levels were significantly associated with early recurrence. Conclusions The adjuvant combination of envafolimab, lenvatinib, and capecitabine demonstrates promising efficacy and a manageable safety profile in high‐risk BTC patients after R0 resection. However, these findings still require validation in larger, multicenter, randomized controlled trials.
Tian et al. (Fri,) studied this question.