The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant immunochemotherapy Toripalimab (JS001) with cisplatin and paclitaxel followed by right thoracic approach esophagectomy with total 2-field lymph node dissection improves the overall survival of thoracic esophageal cancer patients versus neo-adjuvant chemotherapy.
The effect of immunochemotherapy in second line treatment of esophageal cancer got a positive results in the world. We tried to apply the immunotheray in resectable esophageal cancer and have planed this phase III clinical trials. The optimal management of resectable esophageal squamous cell carcinomas may have a new chapter in the era of immunotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Neo-adjuvant chemotherapy(cisplatin and paclitaxel): Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles. JS001, 240mg ivgtt, d3, \>30min, 3week, 2 cycles Surgery: 2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality. Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included). After surgery/ maintain period: JS001, 240mg ivgtt, d3, \>30min, 3week (8 cycles at most)
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, China
RECRUITINGEvent-free survival (EFS)
The date from the beginning of randomization to the date of first record of unresectable disease, distant metastases, local recurrences of any causes, and death of any cause.
Time frame: The date from the beginning of randomization to the date of first record. 3 years EFS
Event-free survival (EFS)
The date from the beginning of randomization to the date of first record of unresectable disease, distant metastases, local recurrences of any causes, and death of any cause.
Time frame: The date from the beginning of randomization to the date of first record. 5 years EFS
pCR
pathological complete response rate
Time frame: within 14 working days after operation
DFS
Disease free survival
Time frame: 3 years DFS
DFS
Disease free survival
Time frame: 5 years DFS
OS
Overall survival rate
Time frame: 3 years OS
OS
Overall survival rate
Time frame: 5 years OS
ORR
The Overall Response Rate. ORR=CR+PR. Criteria: Response Evaluation Criteria in Solid Tumors, RECIST.
Time frame: 3-4 weeks after the last cycle of neoadjuvant treatment
R0 resection rate
the complete resection rate of all tumor under microscope
Time frame: within 14 working days after operation
MPR
MPR rate was defined as the percentage of patients who achieved a major pathological response (residual tumor ≤10%)
Time frame: within 14 working days after operation
EORTC QLQ-C30
EORTC QLQ-C30 repeated measurement model
Time frame: before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
EORTC QLQ-OES18
EORTC QLQ-OES18 repeated measurement model
Time frame: before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
NRS-2002
NRS-2002 repeated measurement model
Time frame: before surgery, 1month, 3 months, 6 months, 9 months, 1 year after operation
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