This is a randomized, double-blind, placebo-controlled Ib/Ⅱ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. The immunotherapy will be given before and after the operation every three weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
major pathologic response rate
The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.
Time frame: Two weeks after surgery.
R0 resection rate
The R0 resection rate of esophagectomy.
Time frame: Two weeks after surgery.
pathological complete response rate
The rate of pathologic 1a after neoadjuvant chemotherapy.
Time frame: Two weeks after surgery.
disease free survival
The 2-year disease free survival of the whole group.
Time frame: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
disease free survival rate
The 2-year disease free survival rate of the whole group.
Time frame: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival
The 2-year event free survival of the whole group.
Time frame: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival rate
The 2-year event free survival rate of the whole group.
Time frame: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
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Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks.
Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.
overall survival rate
The 2-year overall survival rate of the whole group.
Time frame: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
overall survival
The 2-year overall survival of the whole group.
Time frame: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
adverse events rate
The incidence rate of treatment-related adverse events of the whole group assessed by CTCAE v5.0.
Time frame: From the date of randomization to 90 days after the last chemotherapy.