S-1 Combined With Tislelizumab in Patients With Primary Residual Node-negative Esophageal Squamous Cell Carcinoma (ESCC) After Radical Resection With Neoadjuvant Immunotherapy Combined With Chemotherapy, PHASE II STUDY

WeGuo

To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy

2024-04-07

2027-04-30

2028-04-30

Recruiting

Early phase I

45

Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Patients with esophageal squamous cell carcinoma with neoadjuvant immunotherapy combined with chemotherapy (radiotherapy was not planned during the study period); 3. Thoracic esophageal squamous cell carcinoma patients with residual pathologic primary site and lymph node positive (ypT1-4aN0M0) after surgery (8th UICC-TNM stage); 4. The operation was radical resection; 5. Physical status ECOG 0 \~ 1 score; 6. No local recurrence or distant metastasis was found in the examination before postoperative adjuvant treatment; 7. There were no contraindications of chemotherapy or immunotherapy in the evaluation of various organ functions; 8. Understand and sign the informed consent. Exclusion Criteria: 1. Had malignant tumors other than esophageal cancer within 5 years prior to admission (cured localized tumors were not excluded, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, etc.); Prostate cancer patients who received hormone therapy and obtained DFS for more than 5 years were not excluded). 2. Prior history of interstitial lung disease, or pneumonia requiring steroid treatment when enrolled; 3. Receiving systemic steroid therapy (more than 10mg of prednisone per day or equivalent) or other immunosuppressant within 2 weeks prior to randomization; 4. People who have been severely allergic to chemotherapy drugs (fluorouracil) or any monoclonal antibody; 5. Patients with active autoimmune diseases; 6. Patients with active hepatitis 7. According to the judgment of the researcher, there are other circumstances that are not suitable for participation in this study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study was a one-arm open study'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2024-04-09