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Background <p>This study aims to assess the efficacy and safety of a triplet adjuvant regimen consisting of tislelizumab, lenvatinib, and capecitabine following radical resection in patients with biliary tract cancer (BTC).</p> Methods <p>In this open-label, single-arm trial, patients with histologically confirmed BTC who had undergone curative resection were enrolled to receive adjuvant therapy within 4–16 weeks postoperatively. The treatment regimen consisted of tislelizumab (200 mg), lenvatinib (8 mg), and capecitabine (1250 mg/m<sup>2</sup>). The primary endpoint was the 1-year disease-free survival (DFS) rate. Secondary endpoints included median DFS, 2-year DFS rate, and 1- and 3-year overall survival (OS) rates, as well as safety profiles. Exploratory analyses were conducted to evaluate genomic alterations and prognostic biomarkers associated with clinical outcomes.</p> Results <p>Between February 24 and December 31, 2022, a total of 50 patients underwent treatment. As of the data cutoff (April 30, 2025), the median follow-up duration was 29.3 months (95% CI: 27.2–30.4). Intrahepatic cholangiocarcinoma constituted 78% of cases, with TNM stage III or IV observed in 40% of patients and poorly differentiated tumors identified in another 40%. The median DFS was calculated at 12.7 months (95% CI: 6.4–19.0), with DFS rates being reported as 55.5% (95% CI: 51.4%–57.6%) at 1 year and 30.8% (95% CI: 28.6%–32.9%) at 2 years, respectively. Median OS was not reached; however, the 1-year OS rate stood at an impressive figure of 93.8% (95% CI: 91.7%–95.9%) while the 3-year OS rate declined to 54.4% (95% CI: 50.0%–58.4%). By the exploratory analyses, <i>FSIP2</i> mutation was associated shorter DFS (<i>P</i> &lt; 0.001). Treatment-related grade 3 adverse events occurred in 20% of patients, with no treatment-related deaths or grade ≥ 4 toxicities reported.</p> Conclusions <p>Adjuvant tislelizumab, lenvatinib, and capecitabine demonstrated clinical activity and tolerable safety in patients with resected BTC. Despite not meeting the primary endpoint, continued follow-up and further evaluation are warranted to better define the potential role of this combination regimen.</p> Trial registration <p>ClinicalTrials.gov Identifier: NCT05254847; registered prospectively on February 15, 2022.</p>

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Adjuvant tislelizumab, lenvatinib, and capecitabine for resected biliary tract cancer: a prospective phase II trial

  • 期刊论文

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  • 发表日期：

    2026年1月23日

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  • Yun Feng,
  • Ning Zhang,
  • Yi-Ming Zhao,
  • Qi Pan,
  • An-Rong Mao,
  • Wei-Ping Zhu,
  • Ti Zhang,
  • Lu Wang

摘要

Background

This study aims to assess the efficacy and safety of a triplet adjuvant regimen consisting of tislelizumab, lenvatinib, and capecitabine following radical resection in patients with biliary tract cancer (BTC).

Methods

In this open-label, single-arm trial, patients with histologically confirmed BTC who had undergone curative resection were enrolled to receive adjuvant therapy within 4–16 weeks postoperatively. The treatment regimen consisted of tislelizumab (200 mg), lenvatinib (8 mg), and capecitabine (1250 mg/m2). The primary endpoint was the 1-year disease-free survival (DFS) rate. Secondary endpoints included median DFS, 2-year DFS rate, and 1- and 3-year overall survival (OS) rates, as well as safety profiles. Exploratory analyses were conducted to evaluate genomic alterations and prognostic biomarkers associated with clinical outcomes.

Results

Between February 24 and December 31, 2022, a total of 50 patients underwent treatment. As of the data cutoff (April 30, 2025), the median follow-up duration was 29.3 months (95% CI: 27.2–30.4). Intrahepatic cholangiocarcinoma constituted 78% of cases, with TNM stage III or IV observed in 40% of patients and poorly differentiated tumors identified in another 40%. The median DFS was calculated at 12.7 months (95% CI: 6.4–19.0), with DFS rates being reported as 55.5% (95% CI: 51.4%–57.6%) at 1 year and 30.8% (95% CI: 28.6%–32.9%) at 2 years, respectively. Median OS was not reached; however, the 1-year OS rate stood at an impressive figure of 93.8% (95% CI: 91.7%–95.9%) while the 3-year OS rate declined to 54.4% (95% CI: 50.0%–58.4%). By the exploratory analyses, FSIP2 mutation was associated shorter DFS (P < 0.001). Treatment-related grade 3 adverse events occurred in 20% of patients, with no treatment-related deaths or grade ≥ 4 toxicities reported.

Conclusions

Adjuvant tislelizumab, lenvatinib, and capecitabine demonstrated clinical activity and tolerable safety in patients with resected BTC. Despite not meeting the primary endpoint, continued follow-up and further evaluation are warranted to better define the potential role of this combination regimen.

Trial registration

ClinicalTrials.gov Identifier: NCT05254847; registered prospectively on February 15, 2022.