Clinical trial · Interventional
Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.
Neoadjuvant Tislelizumab Combined With Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma : Single Arm Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. This study will provide valuable information for further prospective clinical trials of neoadjuvant anti-PD-1 and other immunotherapy in esophageal cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Esophageal Squamous Cell Cancer | Esophageal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab arm
- description
- Radiotherapy: PTV 41.4Gy in 23 Fractions,5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg/m2) and Cisplatin (75 mg/m2) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)
- interventionNames
- Drug: Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy
Primary outcomes (2)
- measure
- Major Pathological Response Rate
- timeFrame
- From date of surgery to 14 days later
- description
- No more than 10% of tumor cells were found in neoadjuvant surgical specimens.
- measure
- Pathologic complete response rate
- timeFrame
- From date of surgery to 14 days later
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 2. Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0) 3. Eastern Cooperative Oncology Group (ECOG) status 0-1 4. Signed written informed consent prior to the implementation of any trial-related rocedures 5. Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/l Hemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) \> 5 x ULN Bilirubin \> 1.5 х ULN Exclusion Criteria: 1. Patients diagnosed with any other malignant tumor 2. Patients at risk for tracheoesophageal fistula or aortoesophageal fistula 3. Have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor 4. Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding 5. Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment 6. Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction 7. A history of interstitial lung disease or non-infectious pneumonia 8. Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years 9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections 10. Patients who have received allogeneic stem cell or solid organ transplantation 11. Women during pregnancy or lactation
References
Publications (0)
Data not yet available