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<p>Several studies have evaluated PD-1 inhibitors plus chemotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma (ESCC), but comparative data with chemoradiotherapy (CRT) remain limited. This multicenter, randomized, open-label, phase 2 non-inferiority trial (REVO, NCT05007145) assessed the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy (ICT) versus CRT in patients with resectable, locally advanced ESCC. A total of 104 patients were randomized to ICT (camrelizumab, nab-paclitaxel, cisplatin) or CRT (nab-paclitaxel, cisplatin, radiotherapy). The primary endpoint was pathologic complete response (pCR). ICT achieved a pCR rate of 32.7% versus 34.6% with CRT (rate ratio 0.94, 90% CI 0.6–1.49), demonstrating non-inferiority and meeting the pre-specified primary endpoint. Major pathologic response was observed in 42.3% of ICT patients and 57.7% of CRT patients, with R0 resection achieved in 100% of both groups. 1-year disease-free survival was 89.1% versus 78.2%, and 1-year overall survival was 100% versus 92.3% for ICT and CRT, respectively. Grade ≥3 treatment-related adverse events occurred in 19.2% of ICT patients and 33.3% of CRT patients, and surgical complications were reported in 31.1% and 35.9%, respectively. These findings indicate that ICT is a safe and effective neoadjuvant strategy for resectable ESCC with a more favorable safety profile.</p>

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Camrelizumab plus chemotherapy versus chemoradiotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma: Phase 2 randomized trial (REVO)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月3日

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  • Peiyuan Wang,
  • Yujie Chen,
  • Feng Wang,
  • Mingqiu Chen,
  • Buhong Zheng,
  • Derong Zhang,
  • Qingfeng Zheng,
  • Jiezhong Wang,
  • Junqiang Chen,
  • Huaxin Cai,
  • Junhua Liu,
  • Wenshan Zhang,
  • Changhong Lian,
  • Juhui Chen,
  • Yu Lin,
  • Yuanji Xu,
  • Rongfang Huang,
  • Mengxia Lei,
  • Peng Chen,
  • Hao He,
  • Hui Lin,
  • Xiaofeng Chen,
  • Hang Zhou,
  • Weijie Chen,
  • Wenwei Wei,
  • Fengnian Zhuang,
  • Junpeng Lin,
  • Canhua Huang,
  • Ni Guan,
  • Jin Yan,
  • Shujun Liang,
  • Shuoyan Liu,
  • Jiancheng Li

摘要

Several studies have evaluated PD-1 inhibitors plus chemotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma (ESCC), but comparative data with chemoradiotherapy (CRT) remain limited. This multicenter, randomized, open-label, phase 2 non-inferiority trial (REVO, NCT05007145) assessed the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy (ICT) versus CRT in patients with resectable, locally advanced ESCC. A total of 104 patients were randomized to ICT (camrelizumab, nab-paclitaxel, cisplatin) or CRT (nab-paclitaxel, cisplatin, radiotherapy). The primary endpoint was pathologic complete response (pCR). ICT achieved a pCR rate of 32.7% versus 34.6% with CRT (rate ratio 0.94, 90% CI 0.6–1.49), demonstrating non-inferiority and meeting the pre-specified primary endpoint. Major pathologic response was observed in 42.3% of ICT patients and 57.7% of CRT patients, with R0 resection achieved in 100% of both groups. 1-year disease-free survival was 89.1% versus 78.2%, and 1-year overall survival was 100% versus 92.3% for ICT and CRT, respectively. Grade ≥3 treatment-related adverse events occurred in 19.2% of ICT patients and 33.3% of CRT patients, and surgical complications were reported in 31.1% and 35.9%, respectively. These findings indicate that ICT is a safe and effective neoadjuvant strategy for resectable ESCC with a more favorable safety profile.