Clinical trial NCT06889402: Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Cancer
Keywords: Complete pathological response
neoadjuvant
Recurrence
Esophageal Squamous Cell Carcinoma
Survival
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with thoracic esophageal squamous cell carcinoma treated neoadjvant treatment followed by esophagectomy from 2018 to 2023,whose preoperative clnical stage was cT1N+M0/cT2-4aN0-3M0, with potential resectability and the ypstage ypT0N0M0（complete pathological response ）

Brief summary: 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.


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

Primary outcomes:
measure: Disease-Free Survival
timeFrame: The postoperative follow-up period should last for at least one year.
Secondary outcomes:
measure: Overall Survival Rate
timeFrame: The postoperative follow-up period should last for at least one year.
Other outcomes:
measure: Metastasis rate of different parts or organs
timeFrame: The postoperative follow-up period should last for at least one year.
Locations:
city: Beijing
country: China
facility: Section of Esophageal and Mediastinal Oncology, Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
References: