Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC
NCT07549100 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2026-04-23
Summary
This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery.
Secondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.
Conditions
- Locally Advanced Esophageal Squamous Cell Carcinoma
Interventions
- DRUG
-
Tislelizumab Plus Chemotherapy
albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles
Sponsors & Collaborators
-
Shandong Provincial Hospital
lead OTHER_GOV
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-15
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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