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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984342
• Other study ID #: 2023045
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2, 2023
• Est. completion date: June 30, 2029

Study information

• Verified date: August 2023
• Source: Affiliated Cancer Hospital of Shantou University Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2029
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Tislelizumab
Adjuvant Chemotherapy (nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)

Locations

Country	Name	City	State
China	Cancer Hospital of Shantou University Medical College	Shantou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Cancer Hospital of Shantou University Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival rate	disease free survival after surgery	1 years after surgery
Secondary	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