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Poster Display session

120TiP - Neoadjuvant short-course radiotherapy combined with chemotherapy and cadonilimab for patients with locally advanced rectal cancer: A prospective, single-arm phase II trial

Date

07 Dec 2024

Session

Poster Display session

Presenters

Jiawei Rao

Citation

Annals of Oncology (2024) 35 (suppl_4): S1432-S1449. 10.1016/annonc/annonc1687

Authors

J. Rao1, Z. Chen2, Z. Wang1, S. Xu2, J. Peng3, S. Niu4, Y. Bao5, X. Song2, S. Cai6, C. Chen2

Author affiliations

  • 1 Gastroenterology Deaprtment, The First Affiliated Hospital of Sun Yat-sen University, 510080 - Guangzhou/CN
  • 2 Gastroenterology Surgical, The First Affiliated Hospital of Sun Yat-sen University, 510080 - Guangzhou/CN
  • 3 Gastrointestinal Surgical Dept., The First Affiliated Hospital of Sun Yat-sen University, 510080 - Guangzhou/CN
  • 4 Radiotherapy, Sun Yat-Sen University, 510275 - Guangzhou/CN
  • 5 Radiotherapy Department, The First Affiliated Hospital of Sun Yat-sen University, 510080 - Guangzhou/CN
  • 6 Gastroenterology Surgical, the First Affiliated Hospital, Sun Yat-sen University, Guangdong/CN

Resources

This content is available to ESMO members and event participants.

Abstract 120TiP

Background

Neoadjuvant chemoradiotherapy (CRT) is the standard treatment for locally advanced rectal cancer (LARC) as it effectively lowers the risk of local recurrence. However, the risk of distant metastasis remains comparatively high. Several clinical trials have suggested that the combination of short-course radiotherapy (SCRT) and PD-(L)1 inhibitor is likely to improve tumor response and prognosis. Cadonilimab (AK104), a novel bispecific antibody simultaneously targeting PD-1 and CTLA-4, is designed to boost anti-tumor activity with improved safety profile.Thus, Cadonilimab, to SCRT combined with chemotherapy might further increase the clinical beneft and prognosis for LARC patients.

Trial design

This phase II, single-center, single-arm clinical trial aims to evaluated the efficacy and safety of preoperative SCRT combined with CAPEOX (capecitabine and oxaliplatin) and cadonilimab in the treatment of LARC. Patients with histologically confirmed T3-4/N+M0 rectal adenocarcinoma will be enrolled. Other key eligibility criteria include: 18-70 years old, ECOG PS 0-1, treatment-naive and normal organ function. Patients (pts) receives 1 cycle of CAPEOX plus AK104 (10mg/kg iv, d1, q3w) followed by SCRT (25 Gy with daily fractions of 5 Gy, administered at d8-12 ) and 2 cycles of CAPEOX plus AK104 (10mg/kg iv, d1, q3w). Total mesorectal excision(TME) is performed 2 weeks after the last cycle of neoadjuvant treatment. After surgery, pts receive 5 cycles of adjuvant CAPEOX treatment. The primary endpoint is pathological complete response (pCR) rate.The secondary endpoints include major pathologic response rate (MPR), R0 resection rate, 1 and 3-year DFS rate, 1 and 3-year OS rate and safety. A Simon two-stage design was used. If 6 or more of the 15 patients achieved pCR in the first stage, another 22 pts would be accrued to the second stage. Tumor tissues and blood samples are collected for further exploration. As of June 2024, 10 patients have been enrolled. Clinical trial identification ChiCTR2300075658.

Clinical trial identification

Legal entity responsible for the study

Chuangqi Chen.

Funding

Akeso Biopharma Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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