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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06889402
Enrollment
600
Registered
2025-03-21
Start date
2025-04-01
Completion date
2025-04-30
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

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

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.

Interventions

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

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease-Free SurvivalThe 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

MeasureTime frameDescription
Overall Survival RateThe 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

MeasureTime frame
Metastasis rate of different parts or organsThe postoperative follow-up period should last for at least one year.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026