An open-label, non-randomized, phase II study to assess the safety and efficacy of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Cell Carcinoma patients
PRIMARY OBJECTIVES: To determine the R0 resection rate of Borderline Resectable Esophageal Squamous Cell Carcinoma patients who used preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin SECONDARY OBJECTIVES: To evaluate the Pathological Complete Response (pCR) rate, Progression Free Survival (PFS), Relapse Rate, Tumor Regression Grading (TRG) post preoperative chemotherapy, Overall Survival (OS), safety and toxicity of chemotherapy regimen and surgery. EXPLORATORY OBJECTIVES: Exploring the benefits of this treatment strategy in Borderline Resectable Esophageal Squamous Cell Carcinoma patients at a molecular level OUTLINE: Eligible patients receive Sintilimab and cisplatin intravenously on day 1 and albumin-bound paclitaxel intravenously on days 1 and 8. This cycle is repeated every 3 weeks in the absence of disease progression or unacceptable toxicity. Radiological and multidisciplinary assessment is performed after every 2-4 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Route of administration: Intravenous
Route of administration: Intravenously over 30min
Route of administration: Intravenous
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
R0 resection rate of patients who underwent surgery following preoperative treatment
The proportion of people with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Time frame: up to 28 weeks
Pathological complete response rate of patients who received surgery following preoperative treatment
The proportion of patients showing an absence of invasive/in situ cancer after treatment
Time frame: up to 28 weeks
Progression free survival from the date of first drug administration until the date of first documented progression or date of death, whichever came first.
The length of time during and after the treatment of the disease, that a patient lives with the disease without its aggravation
Time frame: up to 28 weeks
Tumor regression rate of patients following preoperative treatment
A decrease in the size of a tumor or the extent of cancer in the body
Time frame: immediately before surgery
Relapse rate of patients who received surgery following preoperative treatment
The number of people with deterioration or recurrence of cancer after a temporary improvement
Time frame: up to 28 weeks
Overall survival from the date of first drug administration until the date of death from any cause
The length of time from the start of treatment that patients diagnosed are still alive
Time frame: up to 28 weeks
Number of patients with adverse events and severity according to NCI CTCAE v5.0
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Summary of the Adverse events experienced during treatment related to the drug used or surgery in this study
Time frame: up to 28 weeks