This study is a prospective, observational clinical study. In this study, 30 patients with resectable locally advanced esophageal squamous carcinoma will be prospectively enrolled and treated with adebrelimab (SHR-1316) combined with nab-paclitaxel and cisplatin preoperatively and adebrelimab (SHR-1316) single-agent adjuvant therapy postoperatively, to observe the efficacy and safety of this treatment modality, and to provide clinical evidence for the use of PD-L1 monoclonal antibody in perioperative treatment of esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All subjects were given 3 cycles of neoadjuvant therapy with adebrelimab (1200 mg D1, IV, Q3W)+Nab-paclitaxel(250 mg/m2 D1,IV,Q3W)+Cisplatin(75 mg/m2 D1,IV,Q3W) preoperatively. Within 4-8 weeks of completion of neoadjuvant therapy, all subjects who were suitable for surgery underwent radical surgery, and patients who underwent radical esophageal cancer with R0 resection were given adebrelimab monotherapy postoperatively until disease recurrence or metastasis, toxicity intolerance, initiation of a new antitumor therapy, subject-initiated request to withdraw from the study, and subject's judgement that the subject needed to be withdrawn from the study. The maximum duration of adebrelimab in the adjuvant phase is 16 cycles.
Peking University Cancer Hospital
Beijing, China
RECRUITINGPathologic complete response rate (pCR)
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
Adverse Events (AE)
Incidence and grade (including serious adverse events and immunization-related adverse events), as determined by NCI-CTCAE 5.0 criteria
Time frame: about 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.
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: Estimate up to 2 years
Event-free survival (EFS)
The length of time between signing the informed consent form and the occurrence of any of the following events: disease progression, disease recurrence, or death from any cause
Time frame: Estimate up to 2 years
1-year event-free survival rate (1-year EFS)
The percentage of subjects who were free of the occurrence of any of the events(disease progression, disease recurrence, or death from any cause) from the start of study enrolment to 12 months later.
Time frame: Estimate up to 2 years
Disease-free survival (DFS)
The time from enrolment (ICF signing) to disease recurrence or death due to disease progression.
Time frame: about 2 years
1-year disease-free survival rate (1-year DFS)
The percentage of subjects who were free of disease recurrence or death from the start of study enrolment to 12 months later.
Time frame: about 2 years
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