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.
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
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
Parallel
Albumin-bound paclitaxel
DrugAlbumin-bound paclitaxel at a dose of 125 mg/m² is administrated intravenously on day 1 and day 8 of each 3-week cycle, for a total of 3 cycles.
Low-dose Short-course Radiotherapy
RadiationNeoadjuvant short-course radiotherapy with a total dose of 10 Gy, delivered in 5 daily fractions of 2.0 Gy per fraction, administered consecutively before systemic combination therapy.
High-dose Short-course Radiotherapy
RadiationNeoadjuvant short-course radiotherapy with a total dose of 15 Gy, delivered in 5 daily fractions of 3.0 Gy per fraction, administered consecutively before systemic combination therapy.
Tislelizumab Combined With Chemotherapy for 3 cycles
DrugAnti-PD-1 monoclonal antibody tislelizumab 200 mg is given by intravenous infusion on day 1 of each 3-week cycle, for up to 3 cycles in the neoadjuvant treatment phase.
Carboplatin (AUC 5)
DrugCarboplatin is given intravenously on day 1 of each cycle at a targeted AUC of 5, repeated every 3 weeks for 3 cycles as part of neoadjuvant combination regimen.
Pathological Complete Response (pCR) Rate
The primary outcome measure is the rate of pathological complete response (pCR) after completion of neoadjuvant treatment. Pathological complete response is defined as the absence of residual invasive cancer cells in the primary esophageal tumor bed and all sampled regional lymph nodes, confirmed by postoperative pathological examination by a qualified pathologist.
Major Pathological Response(MPR) Rate
Major pathological response is defined as the residual tumor burden being ≤10% of the primary tumor bed. This outcome measures the proportion of participants who achieve major pathological response after receiving the study intervention, reflecting the effectiveness of the treatment regimen in reducing tumor burden.
R0 Resection Rate
R0 resection rate refers to the proportion of participants who achieve complete surgical resection with negative surgical margins (no residual tumor tissue at the resection edges), which is an important indicator of surgical efficacy and long-term prognosis.
Incidence of Treatment-Related Adverse Events (CTCAE v5.0)
To evaluate the incidence, type and severity of treatment-related adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 in all enrolled participants.
Objective Response Rate (ORR)
The proportion of participants achieving complete response (CR) or partial response (PR) evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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