Prognostic Analysis of Esophageal Cancer with Complete Pathological Response After Neoadjuvant Therapy

Not yet recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT06889402
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-01
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival	The postoperative follow-up period should last for at least one year.	The time from the postoperative period of the patient to the first occurrence of recurrence or metastasis.

Secondary Outcome Measures

Name	Time	Method
Overall Survival Rate	The postoperative follow-up period should last for at least one year.	the proportion of patients who are still alive for a certain period of time after surgery among all the patients who have undergone the surgical operation.

Trial Locations

Locations (1)

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; 🇨🇳 Beijing, Beijing, China