Actively Recruiting
Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
Led by Shandong Provincial Hospital · Updated on 2026-04-23
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of tislelizumab combined with chemotherapy as a conversion therapy for patients with initially unresectable locally advanced esophageal squamous cell carcinoma (ESCC). This observational study includes 30 patients and aims to determine how many can undergo surgery after treatment. Secondary goals include assessing tumor response, pathological complete response, and safety. Participants will receive albumin-bound paclitaxel (260 mg/m² on day 1 every 3 weeks) plus either cisplatin (75 mg/m²) or carboplatin (AUC = 5), combined with tislelizumab (200 mg on day 2 every 3 weeks) for 2 to 4 cycles. After treatment cycles, tumor staging is reassessed to decide if surgery is feasible, guided by a multidisciplinary team. The main study period lasts up to 12 weeks following treatment initiation. During the study, patients will undergo tumor assessments using standard criteria to measure response, with evaluations at approximately 6 to 16 weeks after starting treatment. Researchers will monitor adverse events from the first dose until 30 days after the last dose. Safety and survival follow-ups are included, and the overall focus is on conversion to surgery and treatment effects within this timeframe.
CONDITIONS
Brief Title
Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study procedures
- Age between 18 and 75 years, inclusive; both males and females eligible
- Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma with initially unresectable locally advanced disease
- Tumors invading adjacent critical structures or with multiple-station or bulky lymph node metastases
- No distant metastasis
- At least one measurable lesion per RECIST version 1.1
- ECOG performance status of 0-1
- Estimated life expectancy of 6 months or more
- Adequate organ function without recent blood transfusions or growth factor use
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during treatment and for 3 months after
- Men with partners of childbearing potential agree to use contraception during treatment and for 3 months after
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- Prior radiotherapy, chemotherapy, hormonal therapy, surgery, or targeted therapy for esophageal cancer
- Evidence of distant metastasis
- History of other malignancies except treated basal cell carcinoma or carcinoma in situ of the cervix
- Prior treatment with anti-PD-1 or anti-PD-L1 agents or hypersensitivity to tislelizumab
- Active or history of autoimmune diseases or related conditions
- Current asthma requiring bronchodilator therapy
- Use of immunosuppressive medications over 10 mg/day prednisone or equivalent within 2 weeks prior
- Clinically significant ascites or pleural effusion requiring drainage
- Uncontrolled or significant cardiovascular disease including certain heart failures, unstable angina, recent myocardial infarction, or arrhythmias
- Coagulation abnormalities or bleeding tendencies
- Gastrointestinal conditions with high bleeding or perforation risk within 3 months prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 12 weeks
Participants receive Tislelizumab plus chemotherapy for 2 to 4 cycles as conversion therapy for unresectable locally advanced esophageal squamous cell carcinoma.
Every 3 weeks for 2 to 4 cycles (in-person visits)
Duration - Up to 30 days after last treatment dose
Participants are monitored for treatment-related adverse events for up to 30 days after the last dose of treatment.
1 to 2 visits depending on adverse event monitoring
Trial Site Locations
Total: 1 location
1
Shandong Provincial Hospital
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
A
ALei Feng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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