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Background <p>Patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) face limited treatment&#xa0;options and poor outcomes. Preclinical evidence supports chemoimmunotherapy as a conversion therapy; therefore, this study aims to evaluate the efficacy and safety of preoperative camrelizumab with paclitaxel and nedaplatin.</p> Methods <p>Patients received a combination of camrelizumab (200 mg), paclitaxel (155 mg/m<sup>2</sup>), and nedaplatin (80 mg/m<sup>2</sup>) every 3 weeks. An efficacy assessment was performed every two cycles using the RECIST v1.1 criteria, and patients in the resected group underwent surgery 4–6 weeks after the last dose. The primary endpoint was 1-year overall survival (OS) rate, while secondary endpoints included surgical conversion rates, pathological response rates, objective response rate (ORR), disease-free survival (DFS), and safety.</p> Results <p>This trial enrolled 141 patients with unresectable ESCC (132 locally advanced [M0], 9 metastatic [M1]) with a median follow-up of 32.2 months. Post-induction ORR was 56.7%. The intention-to-treat (ITT) conversion rate reached 48.9% overall and 50.0% (66/132) in M0 patients (R0: 100%; pathological complete response (pCR): 20.9%; major pathological response: 55.2%). One-year OS was 78.7%. Surgical conversion significantly improved survival overall (median OS: not reached (NR) vs. 14.1 months; hazard ratio (HR) = 0.22; 95% CI, 0.13–0.37; <i>P</i> &lt; 0.0001), with further benefit in objective responders (median OS: NR vs. 20.9 months; HR = 0.30; 95% CI, 0.14–0.61; <i>P</i> &lt; 0.001). Approximately 75.9% of patients experienced treatment-related adverse events (TRAEs), predominantly mild to moderate. Pan-lactylation levels were significantly elevated in non-pCR ESCC compared to pCR tissues. A peritumoral radiomic features-derived model effectively stratified patients into distinct groups with significantly different OS and DFS.</p> Conclusions <p>The chemoimmunotherapy regimen shows promising efficacy as a conversion therapy in improving surgical resectability and survival outcomes with manageable TRAEs, and does not delay surgery.</p> Trial registration number <p>ChiCTR2100046355.</p>

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Preoperative conversion therapy of camrelizumab combined with paclitaxel and nedaplatin for unresectable advanced esophageal squamous cell carcinoma: a phase 2 study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月28日

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  • Jinhong Zhu,
  • Jinfeng Zhang,
  • Xiaodong Ling,
  • Changhong Wang,
  • Yingnan Yang,
  • Yangzhong Xin,
  • Hao Jiang,
  • Hao Liang,
  • Luquan Zhang,
  • Xionghai Qin,
  • Jingle Lei,
  • Chengyuan Fang,
  • Xinxin Yang,
  • Yuning Wang,
  • Wei Meng,
  • Xiaoyuan Wang,
  • Hongxue Meng,
  • Jianqun Ma

摘要

Background

Patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) face limited treatment options and poor outcomes. Preclinical evidence supports chemoimmunotherapy as a conversion therapy; therefore, this study aims to evaluate the efficacy and safety of preoperative camrelizumab with paclitaxel and nedaplatin.

Methods

Patients received a combination of camrelizumab (200 mg), paclitaxel (155 mg/m2), and nedaplatin (80 mg/m2) every 3 weeks. An efficacy assessment was performed every two cycles using the RECIST v1.1 criteria, and patients in the resected group underwent surgery 4–6 weeks after the last dose. The primary endpoint was 1-year overall survival (OS) rate, while secondary endpoints included surgical conversion rates, pathological response rates, objective response rate (ORR), disease-free survival (DFS), and safety.

Results

This trial enrolled 141 patients with unresectable ESCC (132 locally advanced [M0], 9 metastatic [M1]) with a median follow-up of 32.2 months. Post-induction ORR was 56.7%. The intention-to-treat (ITT) conversion rate reached 48.9% overall and 50.0% (66/132) in M0 patients (R0: 100%; pathological complete response (pCR): 20.9%; major pathological response: 55.2%). One-year OS was 78.7%. Surgical conversion significantly improved survival overall (median OS: not reached (NR) vs. 14.1 months; hazard ratio (HR) = 0.22; 95% CI, 0.13–0.37; P < 0.0001), with further benefit in objective responders (median OS: NR vs. 20.9 months; HR = 0.30; 95% CI, 0.14–0.61; P < 0.001). Approximately 75.9% of patients experienced treatment-related adverse events (TRAEs), predominantly mild to moderate. Pan-lactylation levels were significantly elevated in non-pCR ESCC compared to pCR tissues. A peritumoral radiomic features-derived model effectively stratified patients into distinct groups with significantly different OS and DFS.

Conclusions

The chemoimmunotherapy regimen shows promising efficacy as a conversion therapy in improving surgical resectability and survival outcomes with manageable TRAEs, and does not delay surgery.

Trial registration number

ChiCTR2100046355.