Randomized Parallel-Group Phase II Study (NEOTERIC) of Atezolizumab With or Without Tiragolumab After Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer

作者：Wentao Tang, Aiwen Wu, Ping Lan, Chengcheng Liu, Zhenning Wang, Jian Wang, N. Chen, Xianrui Wu, Yurong Jiao, Funan Liu, Tong Li, Y. Shi, Jianmin Xu · 发表于：Journal of Clinical Oncology · 年份：2026 · DOI：10.1200/jco-25-01883 · 被引用次数：6 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Cancer Immunotherapy and Biomarkers

PURPOSE Neoadjuvant chemoradiotherapy (nCRT) is the standard treatment for patients with locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates and long-term outcomes remain suboptimal. This study evaluated the safety and efficacy of atezolizumab (Atezo) with or without tiragolumab (Tira) after nCRT in patients with LARC. METHODS This randomized, parallel-group, phase II study included a safety run-in and a subsequent randomized phase. Eligible patients (cT3N+M0 or cT4NanyM0) received long-course nCRT (45-50.4 Gy in 25-28 fractions with concurrent capecitabine), followed by three 21-day cycles of Atezo (1,200 mg once on day 1 of each cycle), either combined with Tira (600 mg; Atezo + Tira arm) or alone (Atezo arm). Radical surgery was performed 2 weeks after final dose. The primary end point was pCR rate. Secondary end points included 1-year event-free survival (EFS) rate and safety. Outcomes were compared with historical controls. RESULTS At data cutoff (January 6, 2025), three patients were enrolled in safety run-in and received Atezo + Tira. In randomized phase, 55 patients were assigned 1:1 to Atezo + Tira arm (n = 28) or Atezo arm (n = 27). pCR rate was 35.7% (95% CI, 18.6 to 55.9; v historical control [15%] P = .002) in Atezo + Tira arm and 22.2% (95% CI, 8.6 to 42.3; v historical control [15%] P = .293) in Atezo arm. After a median follow-up of 21.55 months (range, 20.67-22.24), 1-year EFS rates were 96.3% (95% CI, 76.5 to 99.5) in Ate...