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. 2025 Aug;21(20):2575-2584.
doi: 10.1080/14796694.2025.2534770. Epub 2025 Jul 30.

ESO-Shanghai 20: phase III clinical trial of anti-PD-1 therapy with local intervention for oligometastatic ESCC

Guangmin Mao  1   2   3   4 , Zhuocheng Xin  1   2   3 , Qingsong Fan  5 , Huijuan Zhu  6 , Jinjun Ye  7 , Long Zhou  8 , Yufeng He  9 , Benhua Xu  10 , Cheng Chen  10 , Zhijun Li  11 , Xiaowei Gu  12 , Xianfeng Li  13 , Xiaomin Wang  14 , Junjun Guo  15 , Zhengyang Xu  16 , Peng Wan  16 , Yunxia Zhang  17 , Fuzheng Zhang  17 , Canhong Huang  18 , Qiong Yi  18 , Jiangqiong Huang  19 , Shixiong Liang  19 , Junqiang Chen  20 , Yu Lin  20 , Qingliang Fang  4 , Yun Chen  1   2   3 , Dashan Ai  1   2   3 , Hongcheng Zhu  1   2   3 , Shengnan Hao  1   2   3 , Qi Liu  1   2   3 , Kuaile Zhao  1   2   3
Affiliations

ESO-Shanghai 20: phase III clinical trial of anti-PD-1 therapy with local intervention for oligometastatic ESCC

Guangmin Mao et al. Future Oncol. 2025 Aug.

Abstract

NCT06190782 (ClinicalTrials.gov).

Keywords: Anti-PD-1 immunotherapy; chemo-immunotherapy; esophageal squamous cell carcinoma; oligometastatic carcinoma; radiotherapy.

Plain language summary

Esophageal cancer is a leading cause of cancer deaths globally, with over 500,000 deaths each year, and it is more common in men. Despite improvements in treatment, the five-year survival rate is still low, at less than 20%. Some patients are diagnosed at an advanced stage and cannot receive the best treatment. Studies have shown that using immunotherapy (anti-PD-1 therapy) can improve survival for patients with metastatic esophageal squamous cell carcinoma. However, these studies failed to differentiate between patients with a limited number of metastases, known as oligometastatic, and those with extensive or widespread metastases. Oligometastatic cancer is considered an intermediate stage of cancer development, and some studies suggest that combining local treatment (like surgery or radiation) with systemic treatment (like chemotherapy or checkpoint inhibition therapy) can improve survival for patients with oligometastatic cancer. But there is limited research on this approach for oligometastatic esophageal cancer. Two smaller studies suggested that adding local treatment to systemic treatment might improve survival for patients with oligometastatic esophageal squamous cell carcinoma. To further investigate this, researchers started a larger, multicenter clinical trial called ESO-Shanghai 20. If the results show that combining local treatment with checkpoint inhibition therapy is safe and effective, it could lead to better treatment options for patients with advanced esophageal squamous cell carcinoma.

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Conflict of interest statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Figures

Figure 1.
Figure 1.
Treatment design of ESO-Shanghai 20. The combined group received a combination of local intervention therapy (radiation, surgery, or ablation) and systemic therapy, and the systemic group received systemic therapy only. R: randomization, RT: radiotherapy treatment, PD-1: anti-PD-1 therapy, anti-PD-1±chemo: anti-PD-1 combined with or without chemotherapy.
Figure 2.
Figure 2.
The flow chart of ESO-Shanghai 20. PFS: progression free survival; OS: overall survival.
Figure 3.
Figure 3.
Diagram of lymph node metastatic lesions. Each box in the figure represents a non-regional lymph node metastatic lesion, regardless of the number of lymph nodes in the area within the box, and regional lymph nodes do not count as the number of distant metastases.
See this image and copyright information in PMC

References

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    2. • These three studies investigated the role of anti-PD-1 immunotherapy combined with chemotherapy in first-line treatment of metastatic or recurrent ESCC, demonstrating that anti-PD-1 with chemotherapy significantly improved progression-free survival and overall survival, thus forming the basis for the systemic treatment regimen in ESO-Shanghai20.

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