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<p>There is an urgent need to identify those who may benefit from immunotherapy-based chemoradiotherapy (CRT) for patients with locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR). This single-arm, phase-II trial (NCT05450029), enrolled 46 treatment-naïve patients with histologically confirmed T<sub>3–4</sub>N<sub>0</sub>M<sub>0</sub> or T<sub>1–4</sub>N<sub>+</sub>M<sub>0</sub> LARC with intermediate or high Immunoscore. Patients received 6 cycles of mFOLFOX6 and long-course radiotherapy (50 Gy in 25 fractions) followed by surgery. Sintilimab was added during CRT (2nd-6th cycle). The primary endpoint, pathologic complete response (pCR) rate, was 65.2% [30/46, 95%CI: 49.7–78.6], with 85.7% (6/7) in high and 61.5% (24/39) in intermediate Immunoscore, meeting the pre-specified primary endpoint. Secondary endpoints included R0 resection rate (97.8%), the clinical tumor response (ORR 93.5%), the complication rate and safety, 3-year event-free survival rate, and 3-year overall survival rate (immature). The most common treatment related adverse event (TRAE) was leukopenia (69.6%, 32/46). The TRAE of Grade 3 occurred in 7 patients (15.2%). Four patients had postoperative complications (all grade ≤2). Here, we showed that PD-1 blockade combined with long-course CRT yielded promising therapeutic effects with a favorable pCR rate and acceptable safety profile among patients with intermediate/high-Immunoscore pMMR LARC.</p>

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Neoadjuvant chemoradiotherapy plus sintilimab in proficient mismatch repair locally advanced rectal cancer with intermediate/high-immunoscore (SILAR): a single-arm phase II trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月21日

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  • Xiaobin Zheng,
  • Huashan Liu,
  • Lishuo Shi,
  • Ziwei Zeng,
  • Xingwei Zhang,
  • Shuangling Luo,
  • Yonghua Cai,
  • Ze Li,
  • Zhanzhen Liu,
  • Yujie Hou,
  • Zuli Yang,
  • Xiaowen He,
  • Jia Ke,
  • Liang Huang,
  • Yanxin Luo,
  • Liang Kang

摘要

There is an urgent need to identify those who may benefit from immunotherapy-based chemoradiotherapy (CRT) for patients with locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR). This single-arm, phase-II trial (NCT05450029), enrolled 46 treatment-naïve patients with histologically confirmed T3–4N0M0 or T1–4N+M0 LARC with intermediate or high Immunoscore. Patients received 6 cycles of mFOLFOX6 and long-course radiotherapy (50 Gy in 25 fractions) followed by surgery. Sintilimab was added during CRT (2nd-6th cycle). The primary endpoint, pathologic complete response (pCR) rate, was 65.2% [30/46, 95%CI: 49.7–78.6], with 85.7% (6/7) in high and 61.5% (24/39) in intermediate Immunoscore, meeting the pre-specified primary endpoint. Secondary endpoints included R0 resection rate (97.8%), the clinical tumor response (ORR 93.5%), the complication rate and safety, 3-year event-free survival rate, and 3-year overall survival rate (immature). The most common treatment related adverse event (TRAE) was leukopenia (69.6%, 32/46). The TRAE of Grade 3 occurred in 7 patients (15.2%). Four patients had postoperative complications (all grade ≤2). Here, we showed that PD-1 blockade combined with long-course CRT yielded promising therapeutic effects with a favorable pCR rate and acceptable safety profile among patients with intermediate/high-Immunoscore pMMR LARC.