Whether the introduction of immunotherapy can transform unresectable esophageal cancer into resectable, or even achieve R0 surgical resection, has not been reported yet. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of unresectable esophageal squamous cell carcinoma.
For patients not eligible for R0 resection (defined as locally advanced unresectable esophageal cancer), preoperative treatment can theoretically transform the tumor into a resectable state. The current significance of transformation therapy is to reduce tumor volume and stage to achieve radical resection, eliminate micrometastases, and prevent a postoperative recurrence. There are few studies on the transformation therapy of esophageal squamous cell carcinoma. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of T4a/N3 esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
tislelizumab combined with chemotherapy
Hongjing Jiang
Tianjin, Tianjin Municipality, China
RECRUITINGR0 Surgical Resection Rate .
R0 resection rate
Time frame: 1 year
Evaluate the rate of pathologic complete response (pCR) to the study regimen
The percentage of pathologic complete response at resection for patients who has completed the study regimen
Time frame: 1 year
Evaluate the rate of main pathologic response (MPR) to the study regimen.
Viable tumor comprised ≤ 10% of resected tumor specimens
Time frame: 1 year
Objective response rate (ORR)
Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions
Time frame: 1 year
Disease-free survival (DFS)
DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer
Time frame: 3 years
Overall survival (OS)
Time from the enrollment to death of any cause
Time frame: 3 years
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