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

NCT06889402 | Not Yet Recruiting

• 1 other identifier: AESCNT01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Complete pathological response; neoadjuvant; Recurrence; Esophageal Squamous Cell Carcinoma; Survival

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival

  The time from the postoperative period of the patient to the first occurrence of recurrence or metastasis.

  The postoperative follow-up period should last for at least one year.

Secondary Outcomes (1)

• Overall Survival Rate

  The postoperative follow-up period should last for at least one year.

Other Outcomes (1)

• Metastasis rate of different parts or organs

  The postoperative follow-up period should last for at least one year.

Study Arms (2)

Recurrence

Patients with complete pathological response after neoadjuvant treatment experience recurrence or metastasis after surgery

Procedure: Neoadjuvant therapy with PD-L1 inhibitor

Non-recurrence

Patients with complete pathological response after neoadjuvant treatment without recurrence or metastasis after surgery

Procedure: Neoadjuvant therapy with PD-L1 inhibitor

Interventions

Neoadjuvant therapy with PD-L1 inhibitor PROCEDURE

During neoadjuvant treatment, patients may receive neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy, or neoadjuvant chemotherapy combined with immunotherapy during the perioperative period.

Also known as: neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy

Non-recurrence; Recurrence

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 ）

You may qualify if:

• 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

You may not qualify if:

• Patients with previous history of malignant tumors
• Patients with multiple primary cancers
• Deficient neoadjuvant treatment or salvage surgery
• Incomplete clinical data

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (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 Municipality, 100021, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Pathologic Complete Response; Recurrence; Esophageal Squamous Cell Carcinoma

Interventions

Neoadjuvant Therapy; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: April 1, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: March 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)