This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery. Secondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.
Study Type
OBSERVATIONAL
Enrollment
30
albumin-bound paclitaxel (260 mg/m², day 1, every 3 weeks \[Q3W\]) plus cisplatin (75 mg/m²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles
Shandong Provincial Hospital
Jinan, Shandong, China
RECRUITINGConversion Surgery Rate
Defined as the proportion of patients with initially unresectable locally advanced esophageal squamous cell carcinoma who become eligible for curative-intent surgical resection after study treatment, as determined by multidisciplinary team (MDT) assessment.
Time frame: Up to 12 weeks after initiation of treatment (after completion of 2-4 treatment cycles
Pathological Complete Response (pCR) Rate
pCR is defined as the absence of residual viable tumor cells in both the primary tumor and regional lymph nodes (ypT0N0)
Time frame: At the time of surgery, approximately 8-16 weeks after initiation of study treatment.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients achieving a best overall response of complete response (CR) or partial response (PR).
Time frame: From baseline to completion of 2-4 cycles of treatment (approximately 6-12 weeks), at post-treatment tumor assessment.
Incidence of Treatment-Related Adverse Events (TRAEs)
TRAEs are defined as adverse events considered by investigators to be related to study treatment.
Time frame: From the first dose of study treatment up to 30 days after the last dose of study treatment.
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