This is a study to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy in resectable locally advanced esophageal squamous cell carcinoma patients
The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of neoadjuvant pembrolizumab plus chemotherapy (carboplatin, paclitaxel). Secondary objectives are: To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess toxicities of neoadjuvant pembrolizumab plus chemotherapy To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Pembrolizumab 200mg i.v. day 1-22-43-64
Carboplatin Area Under the Curve(AUC) = 4-5 i.v. day 1-22-43-64 or Cisplatin 75mg/m2 i.v. day 1-22-43-64
75mg/m2 i.v. day 1-22-43-64
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
tumor response
assess the tumor response (by irRECIST) of neoadjuvant pembrolizumab plus chemotherapy
Time frame: up to 12 months
pathological response
assess the pathological responses (by College of American Pathologists(CAP) classification) of neoadjuvant pembrolizumab plus chemotherapy
Time frame: up to 12 months
Percentage completion of treatment
Percentage completion of treatment in neoadjuvant pembrolizumab plus chemotherapy
Time frame: up to 3 months
Incidence and severity of toxicity
Incidence and severity of toxicity defined to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria
Time frame: up to 12 months
Percentage withdrawal rate from surgery
Percentage withdrawal rate from surgery due to neoadjuvant related complications
Time frame: up to 3 months
Percentage delay of surgery
Percentage delay of surgery due to neoadjuvant related complications
Time frame: up to 3 months
R0 resection rate
R0 resection rate
Time frame: up to 3 months
Incidence and severity of post-operative complications to the Clavien-Dindo classification
Incidence and severity of post-operative complications to the Clavien-Dindo classification
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Time frame: up to 3 months
Disease free survival
Disease free survival
Time frame: up to 24 months
Overall survival
Overall survival
Time frame: up to 24 months