Neoadjuvant nedaplatin and paclitaxel regimen with concurrent radiotherapy for esophageal squamous cell carcinoma: a single-arm phase II clinical trial

Aims To evaluate the efficacy and safety of neoadjuvant concurrent chemoradiotherapy (CCRT) utilizing nedaplatin and paclitaxel in patients with locally advanced esophageal squamous cell carcinoma (ESCC).Patients & methods Locally advanced ESCC patients received two cycles of nedaplatin plus paclitaxel or albumin-bound paclitaxel with concurrent radiotherapy (41.4–50.4 Gy) as neoadjuvant treatment. Immunohistochemical profiling was performed on biopsies and surgical specimens. The primary endpoint was the pathological complete response (pCR) rate.Results Among 49 enrolled patients, 33 underwent surgery, yielding a pCR rate of 30.3%. Overall survival was inferior in resected patients with positive postoperative lymph nodes (HR 3.92, 95% CI 1.30–11.80, p = 0.02, log-rank p = 0.009). Higher FOXP3 expression before (HR 0.14, 95% CI 0.02–1.26, p = 0.08, log-rank p = 0.041) and after (HR 0.23, 95% CI 0.07–0.84, p = 0.03, log-rank p = 0.015) treatment nominally contributed to favorable outcomes. Upregulated TIGIT post-treatment trended toward a poorer prognosis in this surgical cohort (HR 7.10, 95% CI 0.79–63.65, p = 0.08, log-rank p = 0.041).Conclusion Neoadjuvant nedaplatin and paclitaxel-based CCRT demonstrates encouraging preliminary antitumor efficacy. Tumor microenvironment profiling highlights FOXP3 and TIGIT dynamics as potential prognostic indicators. These hypothesis-generating insights warrant further validation in large-scale, randomized controlled trials. Clinical trial registration: Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier is ChiCTR1900024628. Date of registration: 19 July 2019.