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

NCT ID: NCT06889402

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-04-30

Brief Summary

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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

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Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Recurrence

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

Neoadjuvant therapy with PD-L1 inhibitor

Intervention Type PROCEDURE

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

Non-recurrence

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

Neoadjuvant therapy with PD-L1 inhibitor

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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neoadjuvant chemotherapy neoadjuvant chemoradiotherapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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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, China

Site Status

Countries

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China

Facility Contacts

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Xiufeng Wei

Role: primary

15836176692

Xiankai Chen

Role: backup

18239900587

Other Identifiers

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AESCNT01

Identifier Type: -

Identifier Source: org_study_id

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