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

NCT ID: NCT05984342

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2029-06-30

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjuvant Chemotherapy in Combination With Immunotherapy

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

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

nab-paclitaxel; Cisplatin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Cancer Hospital of Shantou University Medical College

OTHER

Sponsor Role: lead

Responsible Party

Shao-bin Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shao-bin Chen

Role: primary

chensb535176@hotmail.com

+8613417000759

Other Identifiers

2023045

Identifier Type: -

Identifier Source: org_study_id