Trial reportCancer medicine2026
Efficacy and Safety of Envafolimab Combined With Capecitabine and Lenvatinib as Postoperative Adjuvant Therapy in Resected Biliary Tract Cancer With High-Risk Recurrence Factors: A Phase II Single-Center Prospective Study.
Trial report in Cancer medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Envafolimab - novel anti-PD-1/PD-L1 antibody in cancer treatment.Frontiers in immunology · 2026Review
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
backgroundBiliary 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.
methodsThis 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
results28 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.
conclusionsThe 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.
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