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January 14, 2026Journal of Clinical Oncology

Phase II trial of neoadjuvant short-course radiotherapy followed by ivonescimab with or without chemotherapy in locally advanced rectal cancer (TRIUNITE-03).

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Authors

HSHaode ShenCCChuan ChenFLFan Li

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Overview

Randomized trial assessed complete response in locally advanced rectal cancer, suggesting ivonescimab may enhance outcomes.

Key Points

  • This trial aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy followed by ivonescimab with or without chemotherapy in locally advanced rectal cancer.
  • Phase II, randomized, open-label trial
  • Eligible patients have histologically confirmed rectal adenocarcinoma with locally advanced disease
  • Two arms: Arm A receives SCRT plus ivonescimab and chemotherapy; Arm B receives SCRT plus ivonescimab monotherapy
  • Response evaluated by MRI, endoscopy, and digital rectal examination
  • Primary endpoint is complete response rate, with secondary endpoints including survival rates and safety.
  • Primary endpoint focuses on complete response rate encompassing pathological complete response and sustained clinical response
  • Expected outcomes include evaluation of major pathological response and safety profile
  • Biomarker analyses aim to identify correlates of treatment response.

Cite This Study

Shen et al. (2026) studied this question.

synapsesocial.com/papers/6966f2fb13bf7a6f02c0072bhttps://doi.org/10.1200/jco.2026.44.2_suppl.tps258
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Short-course radiotherapy followed by ivonescimab and CAPOX as neoadjuvant therapy for locally advanced rectal cancer: A single-arm, phase II trial.2026
  2. 2Node-sparing modified short-course radiotherapy combined with capecitabine and PD-1/CTLA-4 for MSS early, middle, and low rectal cancer (mRCAT-E): An open-label, single-arm, prospective multicenter clinical trial.2026
  3. 3The efficacy and safety of short-course radiotherapy followed by sequential chemotherapy and Cadonilimab for locally advanced rectal cancer: a protocol of a phase II study2024 · 5 citations
  4. 4Total neoadjuvant chemoradiotherapy plus anti PD-1 for mid-to-low locally advanced rectal cancer: study protocol of a prospective, single arm, phase II study (STARS - RC06)2025
  5. 5Comparison of efficacy and side effects between short-course radiotherapy and chemotherapy with or without immunotherapy in the neoadjuvant treatment for patients with locally advanced rectal cancer2025