Status:
RECRUITING
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Affiliated Cancer Hospital of Shantou University Medical College
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 therapeuti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05984342
Start Date
August 2 2023
End Date
June 30 2029
Last Update
August 9 2023
Active Locations (1)
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1
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515031