Neoadjuvant chemoradiotherapy or chemotherapy followed by surgery is the standard treatment for local advanced esophageal cancer (EC). It had been demonstrated that patients who achieve pathologic complete response (pCR) after neoadjuvant treatment had better prognosis. However, the pCR rate were about only 5-10% in neoadjuvant chemotherapy and 20-40% in neoadjuvant concurrent chemoradiotherapy. PD-1 antibody based immunotherapy alone as second-line treatment or combined with chemotherapy as first-line treatment had been proved that could prolong overall survival of EC patients. And a recent phase 3 clinical trial CheckMate 577 reported that, as adjuvant treatment, nivolumab could improve disease-free survival in EC and esophageal-gastric junction cancer. The aim of this study was to evaluate the efficacy and safety of toripalimab, an anti-PD-1 antibody, combined with paclitaxel and cisplatin as neoadjuvant treatment in local advanced esophageal squamous cell carcinoma (ESCC). We hope this combining treatment would increase the pCR rate of neoadjuvant chemotherapy and improve survival of patients, and at the menatime avoid the adverse events of neoadjuvant radiotherapy. This study will provide valuable information for further clinical trials of both Toripalimab and other immune checkpoint inhibition agents in treatment of esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients received toripalimab 240 mg I.V. drip on days 1 and 22.
Patients received paclitaxel of 175mg/m2 I.V. drip on days 1 and 22.
Patients received cisplatin of 70mg/m2 I.V. drip on days 1 and 22.
Beijing Cancer Hospital / Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Pathologic complete response rate
The rate of pathologic complete response rate after neoadjuvant therapy.
Time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years
Objective Response Rate
The percentage of patients having a complete response or a partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Time frame: One month after 2 cycles' treatment of last enrolled subject. Estimate up to 2 years
R0 resection rate
The R0 resection rate of esophagectomy
Time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years
Major pathologic response rate
The percentage of subjects with ≤10% survival tumor cells in the resected specimens after neoadjuvant therapy accounted for all subjects who received surgical treatment.
Time frame: Three weeks after surgery of last enrolled subject. Estimate up to 2 years.
Disease-free survival
The time from enrollment to recurrence of tumor or death.
Time frame: From date of surgery until the date of death from any cause or the date of first documented disease progression whichever came first. Estimate up to three years.
Overall survival
The length of time from enrollment until the time of death
Time frame: From enrollment to death of patients. Estimate up to 5 years.
Adverse events
The incidence of adverse events and the incidence of severe adverse events( grade 3-4) .
Time frame: From enrollment to 60 days after the end protocol treatment
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