Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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Esophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.

Official Title
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Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

Conditions
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Esophageal Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Tislelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 18 and 70 years Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0） undergoing radical esophagectomy ECOG (Eastern Cooperative Oncology Group) : 0-1 No recurrent disease before adjuvant therapy Normal hemodynamic indices before the recruitment Able to understand this study and have signed informed consent Exclusion Criteria: previous or concurrent malignancy Interstitial lung disease Requiring systemic treatment with either corticosteroids or other immunosuppressive medications Known or suspected allergy to chemotherapeutic drugs or Tislelizumab Active autoimmune disease Active hepatitis Those whom the investigator considered unsuitable for inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjuvant Chemotherapy in Combination With Immunotherapy<br>Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery | Drug: Tislelizumab<br>* Adjuvant Chemotherapy （nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)<br>* Other names: Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival rate | disease free survival after surgery | 1 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events | Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0) | within 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal squamous cell carcinoma, immunotherapy, chemotherapy, surgery, adjuvant therapy