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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Esophageal Cancer

Treatments: Procedure: Neoadjuvant therapy with PD-L1 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT06889402

AESCNT01

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Recurrence

Description:

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

Treatment:

Procedure: Neoadjuvant therapy with PD-L1 inhibitor

Non-recurrence

Description:

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

Treatment:

Procedure: Neoadjuvant therapy with PD-L1 inhibitor