Clinical trial · Interventional
Neoadjuvant Short-Course Radiotherapy Plus Tislelizumab and Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Combined With Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: A Prospective, Multicenter, Exploratory 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)
Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Plus Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma This is a prospective, randomized, two-arm, parallel-group, multicenter, exploratory Phase II clinical trial. It aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy followed by tislelizumab combined with chemotherapy in participants with locally advanced resectable esophageal squamous cell carcinoma (ESCC). Eligible participants will be randomized in a 1:1 ratio to receive either low-dose or high-dose short-course radiotherapy, followed by tislelizumab, nab-paclitaxel, and carboplatin for 3 cycles. Surgery will be performed 4-6 weeks after the last neoadjuvant treatment. Primary endpoint: Pathological Complete Response (pCR) rate. Secondary endpoints: Major Pathological Response (MPR) rate, Objective Response Rate (ORR), R0 resection rate, downstaging rate, 3-year Event-Free Survival (EFS), 3-year Overall Survival (OS), safety profile, and quality of life. Approximately 50 participants will be enrolled. Randomization will be stratified by tumor location, clinical T stage, and clinical N stage using a stratified block design via an EDC/IWRS system.
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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma (ESCC) | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Carboplatin (AUC 5) | Drug | Carboplatin | ALIAS |
| High-dose Short-course Radiotherapy | Radiation | — | UNRESOLVED |
| Low-dose Short-course Radiotherapy | Radiation | — | UNRESOLVED |
| Tislelizumab Combined With Chemotherapy for 3 cycles | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low-Dose Radiotherapy + Tislelizumab + Chemotherapy
- description
- Neoadjuvant low-dose short-course radiotherapy (10 Gy in 5 fractions) followed by tislelizumab combined with nab-paclitaxel and carboplatin for 3 cycles, then surgical resection.
- interventionNames
- Drug: Albumin-bound paclitaxel
- Radiation: Low-dose Short-course Radiotherapy
- Drug: Tislelizumab Combined With Chemotherapy for 3 cycles
- Drug: Carboplatin (AUC 5)
- type
- EXPERIMENTAL
- label
- High-Dose Radiotherapy + Tislelizumab + Chemotherapy
- description
- Neoadjuvant high-dose short-course radiotherapy (15 Gy in 5 fractions) followed by tislelizumab combined with nab-paclitaxel and carboplatin for 3 cycles, then surgical resection.
- interventionNames
- Drug: Albumin-bound paclitaxel
- Radiation: High-dose Short-course Radiotherapy
- Drug: Tislelizumab Combined With Chemotherapy for 3 cycles
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily provided written informed consent prior to any study-related procedures * Aged 18 to 75 years, male or female * Life expectancy of at least 3 months * Predicted to achieve R0 surgical resection * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Histologically confirmed, treatment-naive, resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC) meeting the staging criteria: T1 N1-3 M0 or T2-4a N0-3 M0 (T2 ≥3 cm or poorly differentiated). No suspected metastatic cervical lymph nodes (except for upper thoracic esophageal cancer regional lymph nodes) on neck ultrasound or contrast-enhanced CT, and no distant metastasis on imaging * Presence of measurable tumor lesions. * Adequate organ function defined by laboratory parameters: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count ≥100×10⁹/L; hemoglobin ≥90 g/L. Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN. Serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min. INR ≤1.5, PT and APTT ≤1.5×ULN * Men and women of childbearing potential must use effective contraception during treatment and for 6 months after the last dose of study treatment * Good compliance and ability to complete scheduled follow-up. Exclusion Criteria: * Prior treatment with PD-1/PD-L1 inhibitors or other immunomodulatory agents targeting T-cell receptors (e.g., CTLA-4, OX40) * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage * Active or suspected autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, except type 1 diabetes controlled by replacement therapy, hypothyroidism, or skin disorders not requiring systemic therapy * History of grade ≥2 interstitial lung disease * Systemic corticosteroids (\>10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days before first study treatment * Primary or acquired immunodeficiency, organ transplantation, allogeneic hematopoietic stem cell transplantation * Live vaccine within 4 weeks before first study treatment * Severe uncontrolled cardiovascular or cerebrovascular disease: Uncontrolled hypertension or pulmonary hypertension. Unstable angina, myocardial infarction, coronary artery bypass grafting, or stent implantation within 6 months. NYHA class ≥2 chronic heart failure. Left ventricular ejection fraction (LVEF) \<50%. Clinically significant arrhythmia requiring treatment. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months. Uncontrolled active infection requiring systemic antibiotics. Positive HIV test, active hepatitis B or hepatitis C infection (exceptions: HBV DNA \<500 IU/mL; HCV RNA undetectable). Active pulmonary tuberculosis (TB). Other active malignancy within the previous 2 years, except adequately treated thyroid cancer, carcinoma in situ of the cervix, basal/squamous cell skin cancer, or ductal carcinoma in situ of the breast * History of drug abuse or psychiatric disorder * Pregnant or lactating women * Any other severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, would increase study-related risk or interfere with result interpretation.
References
Publications (3)
- RESULTLi C, Han Y, Zhao S, Kang X, Zheng Y, Cao Y, Yan Y, Shi L, Wang X, Lu T, Zou G, Li H, Che J, Xiang J, Zhu L, Hang J, Zhang Y, Jin R, Han D, Chen X, Jing H, Guo W, Cheng Z, Zhao L, Chen X, Yu B, Li J, Li B, Li Y, Li H. Preoperative pembrolizumab (anti-PD-1 antibody) combined with chemoradiotherapy for esophageal squamous cell carcinoma: a phase 1/2 trial (PALACE-2). Signal Transduct Target Ther. 2025 Nov 28;10(1):386. doi: 10.1038/s41392-025-02477-4. PMID 41309527
- RESULTGhalehtaki R, Amini A, Abyaneh R. Optimizing neoadjuvant radiotherapy for locally advanced esophageal squamous cell carcinoma: a comprehensive review on the role of concomitant or sequential immune checkpoint inhibitors. Esophagus. 2025 Jan;22(1):5-18. doi: 10.1007/s10388-024-01097-1. Epub 2024 Nov 19. PMID 39562407
- RESULTHe W, Bai H, Lv J, Tang P, Hu T, Zhou H, Xiao W, Peng L, Liu G, Wang K, Fang Q, Qi Y, Liang L, Zheng X, Qing H, Chen Y, Zhou Y, Xie W, Han Y, Leng X. Neoadjuvant chemotherapy or chemoradiotherapy plus sintilimab versus neoadjuvant chemoradiotherapy for locally advanced oesophageal squamous cell carcinoma: a study protocol of a multicentre, randomised, controlled, phase III trial (SCIENCE study). BMJ Open. 2025 Jun 4;15(6):e095828. doi: 10.1136/bmjopen-2024-095828. PMID 40467307