This is a study to evaluate the efficacy and safety of preoperative treatment with durvalumab combined with neoajuvant therapy (carboplatin, paclitaxel with/without radiation) in locally advanced resectable oesophageal squamous carcinoma.
The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of preoperative treatment with durvalumab combined with neoadjuvant therapy (carboplatin, paclitaxel with/without radiation). Secondary objectives are: To assess completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment. To assess toxicities of durvalumab in combination with chemoradiation. \[Time Frame: up to 1 year\] To assess completion of chemotherapy with/without radiation treatment. 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. \[ Time Frame: up to 24 months \] Overall Survival. \[ Time Frame: up to 24 months \]
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Durvalumab 1500mg i.v. day 1-22-43-64
Chemotherapy
Chemotherapy
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
tumor response
assess the tumor response (by irRECIST) of preoperative treatment with durvalumab combined with neoadjuvant therapy
Time frame: up to 12 months
pathological response
assess the pathological response (by CAP classification) of preoperative treatment with durvalumab combined with neoadjuvant therapy
Time frame: up to 12 months
Percentage completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment
Percentage completion of treatment with durvalumab combined with chemotherapy with/without radiation treatment
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 completion of chemotherapy with/without radiation treatment
Percentage completion of chemotherapy with/without radiation treatment
Time frame: up to 3 months
Percentage withdrawal rate from surgery due to durvalumab related complications
Percentage withdrawal rate from surgery due to durvalumab related complications
Time frame: up to 3 months
Percentage delay of surgery due to durvalumab related complications
Percentage delay of surgery due to durvalumab related complications
Time frame: up to 3 months
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Radiotherapy 23 x 1.8 Gy
R0 resection rate
R0 resection rate
Time frame: up to 3 months
Incidence and severity of post-operative complications to the Dindo classification
Incidence and severity of post-operative complications to the Dindo classification
Time frame: up to 3 months
Progression free survival
Progression free survival
Time frame: up to 24 months
Overall survival
Overall survival
Time frame: up to 24 months