Journal Publication

Neoadjuvant nedaplatin-paclitaxel yields 30.3% pCR in esophageal cancer trial

A single-arm phase II trial found lymph-node status and tumor FOXP3/TIGIT expression tracked survival after chemoradiotherapy in esophageal squamous cell carcinoma.

By AppliedXLJuly 14, 2026

Executive Summary

A neoadjuvant chemoradiotherapy regimen combining nedaplatin and paclitaxel produced a pathological complete response in roughly three in ten patients who went on to surgery for locally advanced esophageal squamous cell carcinoma.
Patients whose lymph nodes remained cancer-positive after surgery had substantially worse overall survival than those who did not, reinforcing lymph node status as a marker of a poorer prognosis after this treatment.
Tumor expression of two immune markers tracked opposite directions with outcome, positioning them as candidate signals for identifying who benefits most from this regimen rather than as established clinical tools.
A single-arm design without a comparator group means the response rate cannot be weighed against an alternative regimen, and the biomarker associations come from a subgroup small enough that they read as hypothesis-generating rather than confirmed.

The result

The trial enrolled 49 patients with locally advanced esophageal squamous cell carcinoma, treating them with two cycles of nedaplatin plus paclitaxel or albumin-bound paclitaxel alongside concurrent radiotherapy of 41.4 to 50.4 Gy before surgery. Of the 49 enrolled, 33 went on to surgery, and pathological review found a complete response in 30.3% of that surgical cohort. Pathological complete response, meaning no viable tumor found in the resected specimen, was the trial's primary endpoint. Neoadjuvant

How it was done

This was a single-arm phase II trial (no comparator group) registered with the Chinese Clinical Trial Registry as ChiCTR1900024628 in July 2019. Investigators paired the neoadjuvant chemoradiotherapy regimen with immunohistochemical profiling of biopsy and surgical specimens, allowing them to test tumor-microenvironment markers against survival outcomes in the subset of patients who underwent resection. The primary measure was the pathological complete response rate; survival analyses by lymph node status and biomarker expression were secondary, exploratory comparisons within the 33-patient surgical cohort. Neoadjuvant

The survival split

Among resected patients, those with positive lymph nodes after surgery had overall survival far worse than those without, a hazard ratio of 3.92 (95% CI 1.30-11.80, p=0.02, log-rank p=0.009). That gap identifies postoperative nodal status as the clearest prognostic marker the trial produced, sharper than either of the biomarker associations it also reported. Neoadjuvant

The biomarker signal

Higher tumor expression of FOXP3, measured both before and after treatment, tracked with more favorable survival, reaching a hazard ratio of 0.23 (95% CI 0.07-0.84, p=0.03, log-rank p=0.015) for the post-treatment measurement. Upregulated TIGIT expression after treatment moved in the opposite direction, trending toward worse prognosis in the surgical cohort with a hazard ratio of 7.10 (95% CI 0.79-63.65, p=0.08, log-rank p=0.041). Both associations sit in a subgroup of 33 patients and did not reach conventional statistical significance on their point estimates, which is why the trial's own conclusion frames them as hypothesis-generating rather than confirmed. Neoadjuvant

What it establishes for practice

Neoadjuvant chemoradiotherapy ahead of surgery is already an established approach for locally advanced esophageal squamous cell carcinoma, so this trial's contribution is less about introducing a new treatment concept than about characterizing how this specific nedaplatin-paclitaxel combination performs and what tumor biology predicts its outcome. The published findings call for validation of both the FOXP3 and TIGIT associations, and of the regimen's response rate against a comparator, in a larger randomized trial. Neoadjuvant

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.