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

March 17, 2025 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Risk Factors for Recurrence and Survival Outcomes of Esophageal Squamous Cell Carcinoma Patients with Complete Pathological Response After Neoadjuvant Therapy：A Multicenter Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • 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
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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 ）

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recurrence
Patients with complete pathological response after neoadjuvant treatment experience recurrence or metastasis after surgery
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.
Other Names:
  • neoadjuvant chemoradiotherapy
  • neoadjuvant chemotherapy
Non-recurrence
Patients with complete pathological response after neoadjuvant treatment without recurrence or metastasis after surgery
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.
Other Names:
  • neoadjuvant chemoradiotherapy
  • neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival
Time Frame: 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.
The postoperative follow-up period should last for at least one year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rate
Time Frame: 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.
The postoperative follow-up period should last for at least one year.

Other Outcome Measures

Outcome Measure
Time Frame
Metastasis rate of different parts or organs
Time Frame: The postoperative follow-up period should last for at least one year.
The postoperative follow-up period should last for at least one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AESCNT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Cancer

Clinical Trials on Neoadjuvant therapy with PD-L1 inhibitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe