This study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Eligible patients are stratified based on pathological lymph node status and receive either toripalimab monotherapy as maintenance treatment or clinical observation only.
Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Initial patients are those with resectable or potentially resectable (T1 N1-3 M0 or T2-3 N0-3 M0) thoracic segment esophageal squamous cell carcinoma (8th UICC-TNM staging); who have undergone surgical resection after 2 cycles of immunotherapy combined with chemotherapy and achieved R0 resection.
Age 18 to 75 years.
Preoperative examinations of various organ functions indicate no surgical contraindications.
Patients with double primary cancers;
Patients with infections requiring treatment;
Patients requiring continuous systemic corticosteroid therapy (Note: Replacement therapy (e.g., for thyroid insufficiency, insulin therapy, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic therapy and is permitted);
Patients with unstable angina within 3 months or myocardial infarction within 6 months;
Parallel
Toripalimab monotherapy
DrugToripalimab monotherapy as maintenance treatment
2-year OS
the percentage of patients in a study who are still alive after 2years
DFS
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death for any reason
OS
OS (Overall Survival) is defined as the time from randomization (or treatment initiation) to death from any cause.
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This trial is not recruiting at the moment. You can still explore other options:
