Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant therapy with PD-L1 inhibitor.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk Factors for Recurrence and Survival Outcomes of Esophageal Squamous Cell Carcinoma Patients with Complete Pathological Response After Neoadjuvant Therapy：A Multicenter Study
Overview
Esophageal cancer is one of the most common malignant tumors worldwide, with high invasiveness and lethality. Currently, the treatment for resectable locally advanced esophageal cancer mainly consists of a treatment model centered on surgical treatment with the participation of multiple disciplines. Neoadjuvant treatment regimens include chemotherapy, chemoradiotherapy, and chemotherapy combined with immunotherapy. Complete pathological response (pCR)is currently regarded as one of the important indicators for evaluating the efficacy of neoadjuvant treatment. Previous studies have shown that 14%-39% of patients with complete pathological response after neoadjuvant treatment still experience recurrence and metastasis within two years after surgery, suggesting that pCR after esophageal cancer surgery does not mean clinical cure. Perhaps there is a highly risk clinical subgroup need to research. Therefore, based on the prospective clinical database of the National Cancer Center and in cooperation with multiple national cancer regional medical centers, this study analyzes and explores the prognosis of patients with locally advanced esophageal squamous cell carcinoma with pCR after neoadjuvant treatment, characterized by the Chinese population.
Interventions
- Procedure Neoadjuvant therapy with PD-L1 inhibitor
During neoadjuvant treatment, patients may receive neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, or neoadjuvant chemotherapy combined with immunotherapy during the perioperative period.
Primary outcome measures
- Disease-Free Survival [Time frame: The postoperative follow-up period should last for at least one year.]
Secondary outcome measures (1)
- Overall Survival Rate [Time frame: The postoperative follow-up period should last for at least one year.]
Eligibility criteria
Inclusion criteria
- Patients treated neoadjvant treatment followed by esophagectomy from 2018 to 2023
- Patients with thoracic esophageal squamous cell carcinoma
- The preoperative clnical stage is cT1N+M0/cT2-4aN0-3M0, with potential resectability
- Patients with complete pathological response (ypT0N0M0)
- Without distant metastasis was found in the preoperative examinations, and the tumor did not directly invade the pancreas, spleen, trachea, aorta or other adjacent organs such as the lungs
Exclusion criteria
- Patients with previous history of malignant tumors
- Patients with multiple primary cancers
- Deficient neoadjuvant treatment or salvage surgery
- Incomplete clinical data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National C — Beijing
Identifiers
NCT: NCT06889402 · AESCNT01