Actively Recruiting
Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC
Led by Shandong Provincial Hospital · Updated on 2026-04-23
30
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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, both males and females eligible
- Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma with initially unresectable locally advanced disease (T4b tumors invading critical adjacent structures or multiple bulky lymph node metastases)
- No distant metastasis
- At least one measurable tumor lesion per RECIST 1.1
- ECOG performance status of 0 or 1
- Estimated life expectancy of at least 6 months
- Adequate organ function without recent blood transfusions or growth factors: ANC ≥1500/mm³, platelets ≥100,000/mm³, hemoglobin ≥9 g/dL, serum creatinine ≤1.5 mg/dL or creatinine clearance ≥60 mL/min, total bilirubin ≤1.5 × ULN, AST and ALT ≤1.5 × ULN
- For women of childbearing potential: negative pregnancy test within 7 days prior to enrollment, not breastfeeding, and agree to use effective contraception during treatment and for 3 months after last dose
- For men with partners of childbearing potential: agree to use effective contraception during treatment and for 3 months after last dose
- Willingness and ability to comply with study procedures, including safety and survival follow-up
You will not qualify if you...
- Prior radiotherapy, chemotherapy, hormonal therapy, surgery, or targeted therapy for esophageal cancer
- Evidence of distant metastasis confirmed by imaging
- History of other cancers except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Prior treatment with anti-PD-1 or anti-PD-L1 agents or known allergy to tislelizumab or its components
- Active or history of autoimmune diseases including autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism
- Current asthma requiring bronchodilator treatment (patients with resolved childhood asthma or vitiligo may be eligible)
- Use of immunosuppressive drugs including systemic corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks before enrollment
- Clinically significant ascites or pleural effusion needing drainage
- Uncontrolled or significant cardiovascular disease such as NYHA class II or higher heart failure, unstable angina, recent myocardial infarction, or serious arrhythmias
- Blood clotting abnormalities or bleeding disorders, or on anticoagulant therapy
- Gastrointestinal conditions with high bleeding or perforation risk within 3 months before enrollment, including esophageal varices, active ulcers, ulcerative colitis, portal hypertension, or tumors with active bleeding
- Any other condition deemed by the investigator to increase risk of gastrointestinal bleeding or perforation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shandong Provincial Hospital
Jinan, Shandong, China, 250000
Actively Recruiting
Research Team
A
ALei Feng
CONTACT
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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