This is a randomized, open, two arm phase II clinical study. 40 patients are included in the exploratory study. The dominant population with higher biomarker positive / IO score was identified to provide the basis for the later phase III study. The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. The treatment cycle was every 3 weeks. The curative effect was evaluated when the treatment cycle was 2, and the resection of esophageal cancer was considered after 3 cycles. Postoperative adjuvant therapy was based on the patient's condition and surgical results; For patients with R0 resection, postoperative adjuvant treatment is not recommended. For patients with R1 / R2 resection, multi-disciplinary joint discussion and consultation are recommended to propose individualized comprehensive treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.
Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks. Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks. Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.
Department of GI Oncology, Peking University Cancer Hospital,
Beijing, Beijing Municipality, China
biomarkers related to pCR
t has a good value in predicting the efficacy of immunotherapy, and is helpful for the accurate formulation of treatment plan and the accurate evaluation of prognosis of patients with esophageal cancer.
Time frame: 9 weeks
Objective Response Rate
Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.
Time frame: 9 weeks
Disease Control Rate
Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.
Time frame: 9 weeks
Disease free survival
The DFS will be defined as the time of patients alive without local recurrence or distant metastasis of disease from the date of the administration of treatment.
Time frame: Time from randomization to patient's tumor progression or death
Overall Survival
OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier
Time frame: The time from the beginning of randomization to death due to any cause.
Safety
Adverse events
Time frame: from first treatment to 90 days after esophagectomy
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