The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. Surgical treatment of early esophageal cancer has a good prognosis, and advanced esophageal cancer often requires a combination of surgery, chemotherapy, radiotherapy and immunotherapy, but the prognosis is still poor. The investigators designed a randomized, controlled, phase II study of perioperative camrelizumab combined with albumin paclitaxel and cisplatin in patients with resectable esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(2-4 cycles Camrelizumab+Albumin Paclitaxel+Cisplatin and Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication
After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGPathologic complete response,pCR
defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory
Time frame: At time of surgery
3 years disease free survival, DFS
Time after R0 resection to disease recurrence or death
Time frame: up to 3 year
Major pathological response(MPR)
defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.
Time frame: At time of surgery
Objective Response Rate (ORR)
CR( complete response)+PR(partial response)
Time frame: up to 2 year
Disease-Free Survival (DFS)
Time after R0 resection to disease recurrence or death
Time frame: up to 5 year
Overall Survival (OS)
defined as the time from randomization to death from any cause during the course of the study.
Time frame: up to 5 year
European Organisation for Research and Treatment of Cancer (EORTC) Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18).
EORTC QLQ-OES18
Time frame: up to 5 year
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After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication
After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Best Supportive Care) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication