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NCT Number: NCT06889402

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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 contact

Xiankai Chen

CONTACT

[email protected]

18239900587

Xiufeng Wei

CONTACT

[email protected]

15836176692

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Metastasis rate of different parts or organs

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

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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