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<p>This is an investigator-initiated, open-label, single-arm, phase II trial that aimed to assess the combination of sintilimab plus anlotinib among patients with treatment-naïve metastatic colorectal cancer (mCRC) (APICAL-CRC ClinicalTrials.gov number, NCT04271813). Between June 2020 and September 2023, a total of 30 patients were eventually enrolled and received the study regimen. Among these 30 patients, 50% had an Eastern Cooperative Oncology Group(ECOG) score of 0–1, and the other 50% had a score of 2. The objective response rates (ORRs) were 48.3% (95% CI 29.4–67.5) in the efficacy-evaluable cohort and 46.7% (95% CI 28.3–65.7) in the intent-to-treat (ITT) cohort. Twelve patients had stable disease, and the disease control rates (DCRs) were 89.7% (95% CI 72.6–97.8) and 86.7% (95% CI 69.3–96.2) in the efficacy-evaluable and ITT cohorts, respectively. The median progression-free survival (mPFS) was 8.6 months (95% CI 4.8–11.0), and the median overall survival (mOS) reached 22.9 months (95% CI 13.5–36.3). Treatment-related adverse events (TRAEs) of any grade were reported in 23 patients (76.7%), and grade 3 TRAEs occurred in 4 patients (13.3%). Multivariate Cox regression analysis revealed that the presence of liver metastases was an independent prognostic factor for poor PFS (HR = 5.66, 95% CI 1.58–20.2) and OS (HR = 7.85, 95% CI 1.38–44.8), whereas <i>FLT</i> mutation was independently associated with poor OS(HR = 12.5, 95% CI 1.54–101). This trial demonstrated that sintilimab plus anlotinib exhibited promising antitumor efficacy along with a manageable safety profile among treatment-naïve mCRC patients.</p>

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Anlotinib plus sintilimab as first-line treatment for patients with advanced colorectal cancer (APICAL-CRC): an open-label, single-arm, phase II trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月16日

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  • Zhan Wang,
  • Bao-Dong Qin,
  • Chen-Yang Ye,
  • Miao-Miao Wang,
  • Ling-Yan Yuan,
  • Hou-Shan Yao,
  • Xiao-Dong Jiao,
  • Ke Liu,
  • Wen-Li Zhou,
  • Wen-Xing Qin,
  • Li Sun,
  • Wei-Ping Dai,
  • Yan Ling,
  • Ying Wu,
  • Shi-Qi Chen,
  • Ying-Fu Zhang,
  • Dong-Min Shi,
  • Xiao-Peng Duan,
  • Xue Zhong,
  • Xi He,
  • Wen-Xin Zhai,
  • Bei Zhang,
  • Da-Dong Zhang,
  • Ning Gao,
  • Yuan-Sheng Zang

摘要

This is an investigator-initiated, open-label, single-arm, phase II trial that aimed to assess the combination of sintilimab plus anlotinib among patients with treatment-naïve metastatic colorectal cancer (mCRC) (APICAL-CRC ClinicalTrials.gov number, NCT04271813). Between June 2020 and September 2023, a total of 30 patients were eventually enrolled and received the study regimen. Among these 30 patients, 50% had an Eastern Cooperative Oncology Group(ECOG) score of 0–1, and the other 50% had a score of 2. The objective response rates (ORRs) were 48.3% (95% CI 29.4–67.5) in the efficacy-evaluable cohort and 46.7% (95% CI 28.3–65.7) in the intent-to-treat (ITT) cohort. Twelve patients had stable disease, and the disease control rates (DCRs) were 89.7% (95% CI 72.6–97.8) and 86.7% (95% CI 69.3–96.2) in the efficacy-evaluable and ITT cohorts, respectively. The median progression-free survival (mPFS) was 8.6 months (95% CI 4.8–11.0), and the median overall survival (mOS) reached 22.9 months (95% CI 13.5–36.3). Treatment-related adverse events (TRAEs) of any grade were reported in 23 patients (76.7%), and grade 3 TRAEs occurred in 4 patients (13.3%). Multivariate Cox regression analysis revealed that the presence of liver metastases was an independent prognostic factor for poor PFS (HR = 5.66, 95% CI 1.58–20.2) and OS (HR = 7.85, 95% CI 1.38–44.8), whereas FLT mutation was independently associated with poor OS(HR = 12.5, 95% CI 1.54–101). This trial demonstrated that sintilimab plus anlotinib exhibited promising antitumor efficacy along with a manageable safety profile among treatment-naïve mCRC patients.