Neoadjuvant Short-Course Radiotherapy Plus Tislelizumab and Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Starting soon · Phase 2

Conditions studied: Esophageal Squamous Cell Carcinoma (ESCC)

In brief

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.

Key facts

Study ID: NCT07678580
Run by: Tang-Du Hospital
People needed: 50
Starts: 2026-07-10
Expected to finish: 2029-06-30
Last updated by the study team: 2026-07-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Tangdu Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China

Full record on ClinicalTrials.gov

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