The Efficacy of Tislelizumab Combined With S-1 in Patients With Residual Primary Lesions and Node-Negative Esophageal Squamous Cell Carcinoma After Neoadjuvant Immunochemotherapy Followed by Curative Resection: A Phase II, Multicenter Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To explore the safety and efficacy of Tegafur combined with tislelizumab in patients with esophageal squamous cell carcinoma with residual primary lesion and node-negative after radical resection following neoadjuvant immunotherapy combined with chemotherapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ Age 18-75 years old, gender is not limited;

⁃ Patients with esophageal squamous cell carcinoma with neoadjuvant immunotherapy combined with chemotherapy (radiotherapy was not planned during the study period);

⁃ Thoracic esophageal squamous cell carcinoma patients with residual pathologic primary site and lymph node positive (ypT1-4aN0M0) after surgery (8th UICC-TNM stage);

⁃ The operation was radical resection;

⁃ Physical status ECOG 0 \

• 1 score;

⁃ No local recurrence or distant metastasis was found in the examination before postoperative adjuvant treatment;

⁃ There were no contraindications of chemotherapy or immunotherapy in the evaluation of various organ functions;

⁃ Understand and sign the informed consent.

Locations
Other Locations
China
Army Medical Center of the People's Liberation Army
RECRUITING
Chongqing
Contact Information
Primary
Wei Guo
gyguowei@hotmail.com
+86 13527323568
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 45
Treatments
Experimental: S-1 Combined With Tislelizumab
tegafur (S-1) 80mg/100mg/120mg Q3W (discontinued at the third week) + tislelizumab 200 mg Q3W, treatment for 1 year. tegafur: body surface area (BSA) \< 1.25m2, use 80mg; 1.25-1.5m2, use 100mg; \> 1.5m2, use 120mg. Treatment for 1 year
Related Therapeutic Areas
Sponsors
Leads: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

This content was sourced from clinicaltrials.gov