Actively Recruiting
Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma
Led by Ming-Yu Lien · Updated on 2026-02-27
45
Participants Needed
8
Research Sites
170 weeks
Total Duration
On this page
Sponsors
M
Ming-Yu Lien
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase II, open-label, single-arm, multicenter study evaluating the safety and efficacy of combining Tislelizumab with induction chemoradiotherapy (CRT), followed by conversion surgery, in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC). Patients will receive induction CRT with weekly paclitaxel and cisplatin along with Tislelizumab, followed by two cycles of consolidation Tislelizumab-chemotherapy. If the tumor becomes resectable, patients will undergo surgery. The primary goal is to assess the 2-year overall survival (OS) rate. Secondary outcomes include pathological complete response (pCR), conversion rate, R0 resection rate, disease-free survival (DFS), recurrence-free survival (RFS), and treatment-related adverse events.
CONDITIONS
Official Title
Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed squamous-cell carcinoma of the esophagus
- Clinical T4 cancer or unresectable metastatic regional lymph nodes or CT evidence of M1Lym
- At least 20 years old
- Eastern Cooperative Oncology Group performance-status score of 0 or 1
- Adequate major organ function including WBC ≥ 3,500/mm3, hemoglobin ≥ 9.0 g/dL, platelet ≥ 80,000/mm3
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- ALT and AST ≤ 5 times ULN and ≤ 200 U/L
- PT, aPTT and INR ≤ 1.5 times ULN
- Albumin ≥ 2.5 g/dL
- Creatinine clearance ≥ 50 ml/min
- Women of childbearing potential must agree to contraception from consent until 5 months after last dose
- Men must agree to use contraception from treatment start until 3 months after last dose
- Willingness to undergo definitive resection with lymph node dissection
- Signed written informed consent form
You will not qualify if you...
- Prior systemic therapy for advanced ESCC
- Presence of distant metastases including liver, lung, bone, or brain
- Esophageal perforation or fistula
- Tumor bleeding
- Active infections such as tuberculosis
- Known HIV infection
- Active or suspected autoimmune disease except certain controlled conditions
- Systemic immunosuppression or chronic steroid therapy over 10mg daily prednisolone
- Known hepatitis B or C virus infection unless stable or treated per guidelines
- Prior therapy targeting T-cell costimulating or immune-checkpoint pathways
- Malignancies within last 3 years except certain skin or cervical cancers
- Major surgery within 4 weeks prior to enrollment
- Pregnant or nursing women, or positive pregnancy test
- History of allogeneic stem cell or organ transplantation
- Uncontrolled significant cardiovascular or cerebrovascular diseases within 6 months
- Interstitial lung disease, pneumonitis, or uncontrolled lung diseases
- Receipt of live or live-attenuated vaccine within 30 days before first dose
- Any other condition judged inappropriate by investigators
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Not Yet Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Not Yet Recruiting
3
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
4
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Not Yet Recruiting
5
National Cheng Kung University Hospital
Tainan, Taiwan
Not Yet Recruiting
6
National Taiwan University Hospital
Taipei, Taiwan, 100225
Not Yet Recruiting
7
Taipei Veterans General Hospital
Taipei, Taiwan
Not Yet Recruiting
8
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Not Yet Recruiting
Research Team
M
Ming-Yu Lein, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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