RecruitingPhase 2NCT06354140

PPIO-008 Tislelizumab Combined With S-1 in Patients With ypT+N0 ESCC After Radical Resection With Neoadjuvant STUDY

The Efficacy of Tislelizumab Combined With S-1 in Patients With Residual Primary Lesions and Node-Negative Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy Followed by Curative Resection: A Phase II, Multicenter Trial

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Enrollment

45 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

Age 18-75 years old, gender is not limited;
Patients with esophageal squamous cell carcinoma with neoadjuvant immunotherapy combined with chemotherapy (radiotherapy was not planned during the study period);
Thoracic esophageal squamous cell carcinoma patients with residual pathologic primary site and lymph node positive (ypT1-4aN0M0) after surgery (8th UICC-TNM stage);
The operation was radical resection;
Physical status ECOG 0 \~ 1 score;
No local recurrence or distant metastasis was found in the examination before postoperative adjuvant treatment;
There were no contraindications of chemotherapy or immunotherapy in the evaluation of various organ functions;
Understand and sign the informed consent.

Exclusion Criteria7

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).
Prior history of interstitial lung disease, or pneumonia requiring steroid treatment when enrolled;
Receiving systemic steroid therapy (more than 10mg of prednisone per day or equivalent) or other immunosuppressant within 2 weeks prior to randomization;
People who have been severely allergic to chemotherapy drugs (fluorouracil) or any monoclonal antibody;
Patients with active autoimmune diseases;
Patients with active hepatitis
According to the judgment of the researcher, there are other circumstances that are not suitable for participation in this study.

Interventions

DRUGTegafur

Tegafur (S-1) 80mg/100mg/120mg Q3W (discontinued at the third week) + tislelizumab 200 mg Q3W, treatment for 1 year. Tegafur: body surface area (BSA) \< 1.25m2, use 80mg; 1.25-1.5m2, use 100mg; \> 1.5m2, use 120mg. Treatment for 1 year