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

Phase 1

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Tislelizumab

• Registration Number: NCT05984342
• Lead Sponsor: Affiliated Cancer Hospital of Shantou University Medical College

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-02
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09
• Primary Completion: 2025-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjuvant Chemotherapy in Combination With Immunotherapy	Tislelizumab	Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery

Primary Outcome Measures

Name	Time	Method
disease-free survival rate	1 years after surgery	disease free survival after surgery

Secondary Outcome Measures

Name	Time	Method
Rate of adverse events	within 6 months	Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)

Trial Locations

Locations (1)

Cancer Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China