RecruitingNCT05740995

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

A Single-center, Prospective Cohort Study of Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Sponsor

Shanghai Zhongshan Hospital

Enrollment

40 participants

Start Date

Dec 1, 2020

Study Type

OBSERVATIONAL

Conditions

Esophageal Squamous Cell Carcinoma Neoadjuvant Chemoimmunotherapy

Summary

The purpose of this study is to evaluate the outcomes and identify predictors of neoadjuvant anti-PD-1 plus chemotherapy in locally advanced resectable esophageal squamous cell carcinoma (ESCC). In this single-center cohort study, we are aiming to (1) evaluate the therapeutic efficacy and survival benefits on patients with locally advanced resectable ESCC (cT3-4aN0-1M0); (2) evaluate the value of genomic indicators including MMR alternation status in predicting therapeutic responses and prognosis; (3) evaluate the value of transcriptomic indicators including B cell lineage features in predicting therapeutic responses and prognosis; (4) evaluate the value of microbial and metabolite indicators in predicting therapeutic responses and prognosis. Whole exome sequencing, RNA sequencing, 16S rRNA sequencing and Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) of samples of patients to neoadjuvant chemoimmunotherapy before and after treatment are performed to explore the mechanisms of drug resistance and identification of predictive and prognosis biomarkers.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an anti-PD-1 immunotherapy drug to chemotherapy given before surgery can improve outcomes in people with locally advanced but potentially removable esophageal squamous cell carcinoma (cancer of the food pipe). **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed squamous cell cancer of the esophagus located in the chest cavity - Your cancer is locally advanced but has not spread to distant organs (stage T3–T4a, no distant metastasis) - You are in good health (ECOG performance status 0–1) - Your heart, lung, blood, liver, and kidney function meet the required thresholds **You may NOT be eligible if...** - Your cancer is not squamous cell type (e.g., adenocarcinoma) - Your cancer has spread to other organs - Your cancer is early stage (T1–T2, no lymph nodes) - You have serious autoimmune or chronic inflammatory conditions - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGneoadjuvant anti-PD-1 plus chemotherapy

Patients will be given preoperative treatment as below once recruited: 1. Chemotherapy is delivered and composed of two cycles of Nab-paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 3 weeks; 2. PD-1 antibody is delivered 200 mg (iv, in 30 minutes) every 3 weeks; 3. After neoadjuvant therapy of 3-4 cycles, esophagectomy is performed. We advise starting 4 cycles of identical chemoimmunotherapy in 6w after surgery.

Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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