Actively Recruiting
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Led by Affiliated Cancer Hospital of Shantou University Medical College · Updated on 2023-08-09
50
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 70 years
- No prior treatments before surgery such as radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Histologically confirmed squamous cell carcinoma of the thoracic esophagus with positive lymph nodes (T1-3N1-3M0)
- Undergoing radical esophagectomy
- ECOG performance status of 0 or 1
- No recurrent disease before starting adjuvant therapy
- Normal hemodynamic indices before joining the study
- Able to understand the study and provide informed consent
You will not qualify if you...
- Previous or concurrent malignancy
- Interstitial lung disease
- Need for systemic treatment with corticosteroids or other immunosuppressive medications
- Known or suspected allergy to chemotherapy drugs or Tislelizumab
- Active autoimmune disease
- Active hepatitis
- Considered unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China, 515031
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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