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Background <p>Efficacy of second-line treatments after first-line platinum-based chemotherapy in advanced cervical cancer is modest. This open-label, single-arm, multicentre, proof-of-concept phase 2 study evaluated fruquintinib plus sintilimab in advanced cervical cancer.</p> Methods <p>Patients recruited between July 2021 and June 2022 had received at least first-line platinum-based chemotherapy or were unable to receive standard treatment in China. Patients received fruquintinib 5 mg once daily orally (2 weeks on/1 week off) plus sintilimab 200 mg intravenously every 3 weeks. Efficacy and safety analyses included patients who had received at least one dose of study drug.</p> Results <p>Here we show the results of 34 patients who received treatment; 28 (82%) have prior systemic antitumour therapy, with 19 (68%) pretreated patients having programmed death ligand 1 (PD-L1) combined positive score (CPS)&#xa0;≥&#xa0;1. The objective response rate (ORR) is 32% (95% confidence interval [CI] 17–51), meeting the prespecified effective boundary, and the disease control rate (DCR) is 97% (95% CI 85–100). Median progression-free survival (PFS) and overall survival (OS) are 8.3 months (95% CI 5.5–19.4) and 23.5 months (95% CI 15.8–not estimable [NE]), respectively. The most common grade ≥&#xa0;3 treatment-related adverse event is palmar-plantar erythrodysaesthesia syndrome (21%). In pretreated patients with PD-L1&#xa0;CPS&#xa0; ≥ 1, ORR is 37% (95% CI 16–62), median PFS is 19.4 months (95% CI 4.0–22.1), and OS rate at 18 months is 72% (95% CI 46–87).</p> Conclusions <p>Fruquintinib plus sintilimab may indicate favourable and durable antitumour activity with a manageable safety profile in advanced cervical cancer, especially in pretreated patients with PD-L1&#xa0;CPS&#xa0;≥1, warranting further investigation.</p>

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Fruquintinib plus sintilimab in advanced cervical cancer: an open-label, multicentre, phase 2 study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月21日

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  • Xiaohua Wu,
  • Danbo Wang,
  • Jing Wang,
  • Yi Huang,
  • Tienan Yi,
  • Guiling Li,
  • Jieqing Zhang,
  • Keming Wang,
  • Yu Kang,
  • Anwen Liu,
  • Xiaotian Han,
  • Xuemei Ren,
  • Li Li,
  • Runfeng Yang,
  • Quan Li,
  • Qing Yang,
  • Bingbing Zhao,
  • Juan Wang,
  • Hanjie Yi,
  • Yue Tan,
  • Keyan Chen,
  • Puhan Lu,
  • Haiyan Shi,
  • Panfeng Tan,
  • Songhua Fan,
  • Michael M. Shi,
  • Weiguo Su

摘要

Background

Efficacy of second-line treatments after first-line platinum-based chemotherapy in advanced cervical cancer is modest. This open-label, single-arm, multicentre, proof-of-concept phase 2 study evaluated fruquintinib plus sintilimab in advanced cervical cancer.

Methods

Patients recruited between July 2021 and June 2022 had received at least first-line platinum-based chemotherapy or were unable to receive standard treatment in China. Patients received fruquintinib 5 mg once daily orally (2 weeks on/1 week off) plus sintilimab 200 mg intravenously every 3 weeks. Efficacy and safety analyses included patients who had received at least one dose of study drug.

Results

Here we show the results of 34 patients who received treatment; 28 (82%) have prior systemic antitumour therapy, with 19 (68%) pretreated patients having programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 1. The objective response rate (ORR) is 32% (95% confidence interval [CI] 17–51), meeting the prespecified effective boundary, and the disease control rate (DCR) is 97% (95% CI 85–100). Median progression-free survival (PFS) and overall survival (OS) are 8.3 months (95% CI 5.5–19.4) and 23.5 months (95% CI 15.8–not estimable [NE]), respectively. The most common grade ≥ 3 treatment-related adverse event is palmar-plantar erythrodysaesthesia syndrome (21%). In pretreated patients with PD-L1 CPS  ≥ 1, ORR is 37% (95% CI 16–62), median PFS is 19.4 months (95% CI 4.0–22.1), and OS rate at 18 months is 72% (95% CI 46–87).

Conclusions

Fruquintinib plus sintilimab may indicate favourable and durable antitumour activity with a manageable safety profile in advanced cervical cancer, especially in pretreated patients with PD-L1 CPS ≥1, warranting further investigation.