Clinical trial NCT05984342: Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Official title: Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
immunotherapy
chemotherapy
surgery
adjuvant therapy
Lead sponsor: Affiliated Cancer Hospital of Shantou University Medical College
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 70 years
2. Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
3. Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0）
4. undergoing radical esophagectomy
5. ECOG (Eastern Cooperative Oncology Group) : 0-1
6. No recurrent disease before adjuvant therapy
7. Normal hemodynamic indices before the recruitment
8. Able to understand this study and have signed informed consent

Exclusion Criteria:

1. previous or concurrent malignancy
2. Interstitial lung disease
3. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications
4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab
5. Active autoimmune disease
6. Active hepatitis
7. Those whom the investigator considered unsuitable for inclusion

Primary outcomes:
measure: disease-free survival rate
timeFrame: 1 years after surgery
Secondary outcomes:
measure: Rate of adverse events
timeFrame: within 6 months
Other outcomes:
Locations:
city: Shantou
country: China
facility: Cancer Hospital of Shantou University Medical College
state: Guangdong
Study officials:
References: