Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Cli… (NCT07332221) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial
435 participantsStarted 2026-01-20
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. The following laboratory tests confirm that bone marrow, liver, and kidney functions meet the study requirements:
✓. No postoperative chemotherapy, radiotherapy, or hormone therapy for malignant tumors has been administered; no history of other malignancies, excluding prostate cancer patients who have received hormone therapy and achieved disease-free survival (DFS) for over 5 years.
✓. Physical status ECOG score 0 to 1.
✓. Women of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after study completion; serum or urine pregnancy test within 7 days before study enrollment must be negative, and patients must be non-lactating; men must agree to use contraceptive measures during the study and for 6 months after study completion.
✕. 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;
✕. Patients with psychiatric disorders;
✕. Patients with existing or concurrent hemorrhagic disorders;
✕. Female patients who are pregnant or breastfeeding;
✕. Patients with bronchial asthma requiring intermittent use of bronchodilators or medical intervention;