Study of Neoadjuvant Anti-PD-1 and Chemotherapy in Adults with Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are studying the outcomes and predictors of neoadjuvant anti-PD-1 plus chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma ESCC. This single-center cohort study aims to assess the treatments therapeutic efficacy and survival benefits, as well as evaluate genomic, transcriptomic, microbial, and metabolite indicators that might predict therapeutic responses and prognosis. Advanced techniques like whole exome sequencing, RNA sequencing, 16S rRNA sequencing, and liquid chromatography with tandem mass spectrometry are used to explore drug resistance mechanisms and identify biomarkers. Patients receive preoperative treatment consisting of two cycles of chemotherapy with Nab-paclitaxel and cisplatin every three weeks, alongside PD-1 antibody infusions every three weeks. After completing 3-4 cycles of this neoadjuvant chemoimmunotherapy, patients undergo esophagectomy surgery. It is recommended to continue four cycles of the same chemoimmunotherapy within six weeks after surgery. During the study, participants provide biological samples before and after treatment for detailed analysis. Researchers monitor major pathological regression MPR rates up to six months from enrollment and assess additional outcomes like pathological response, objective response rate, overall survival, and progression-free survival for up to 36 months after the last participant joins. The study also tracks correlations between genomic, immune, microbial, and metabolite features with treatment responses, aiming to guide future clinical decisions.

Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma