Additional Consolidative Esophagectomy for the Patients With Oligometastatic Resectable ESCC

This study was designed as a multicenter, open-label, randomized controlled prospective clinical study. The experimental group (group A) received additional esophagectomy after 3-month systemic treatment, and the control group (group B) received only systemic treatment. 2-year OS, 3-year PFS and OS were observed in the two groups.

Inclusion criteria

• Histologically confirmed ESCC, and stage was evaluated as cT1-4aN0-3 with oligometastases at initial treatment(According to UICC TNM version 8).

*Oligonucleotides transfer is defined as: there are 3 or less than 3 lesions in single organ(lung, liver, brain or bone), and could be resected, radiofrequency ablation or radiotherapy in 1 radiation fied; Supraclavicular lymph node metastasis is defined as a distant metastases, celiac axis lymph nodes are considered as regional lymph nodes for the patients with lower 1/3 ESCC; Supraclavicular lymph nodes in patients with upper thoracic and cervical esophageal cancer were defined as regional lymph nodes, while abdominal trunk lymph nodes were considered as distant metastases；

• No new metastatic lesions were found after more than 3 months of systemic treatment, and primary esophageal cancer lesions and regional lymph nodes can be resected R0;
• No serious internal disease, KPS score ≥90;
• The evaluation of various organ functions can tolerate surgery, radiotherapy and other treatments;
• The following laboratory tests confirmed that bone marrow, liver and kidney function met the requirements for study participation: Hemoglobin ≥9.0g/L; White blood cell count ≥3.5×109/L; Neutrophil absolute value (ANC) ≥1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤1.5 times the upper limit of normal value; ALT and AST≤2 times the upper limit of normal value; The international standardized ratio of prothrombin time was less than 1.5 times the upper limit of normal value, and part of the thrombin time was within the normal range; Creatinine ≤1.5 times the upper limit of normal value;
• Physical state ECOG 0-1;
• Subject must understand and sign the informed consent form.

Exclusion criteria

• Patients with double primary cancer;
• mental patients;
• Patients with parotid or salivary gland diseases;
• Mediastinal lymph nodes could not be thoroughly dissected during radical resection of esophageal cancer; Or the oligometastatic lesions cannot receive local treatment due to location and other reasons;
• Patients with severe emphysema and pulmonary fibrosis;
• Active infections requiring medical treatment;
• Existing or co-existing hemorrhagic disease;
• Other uncontrollable patients who cannot tolerate chemoradiotherapy or surgery;
• Patients who cannot be thoroughly cleaned due to previous operations;
• Pregnant or lactating female patients.