This is a single-arm,open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
The 1st to 3rd doses were administered concurrently with FP regimen chemotherapy, 200 mg Tislelizumab each, on D1, D22 and D43 by intravenous infusion. In patients with successful conversion, one dose of 200 mg was administered 21 days after surgery in concurrent with the 4th to 6th cycles of 5-Fu, then 6 cycles of 200 mg Tislelizumab as adjuvant therapy; in patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
A FP regimen with 5-Fu 850mg/m\^2 d1-4 + cis-platinum 850mg/m\^2 d1-4 was used, on D1, D22 and D43 infused intravenously. 3 cycles of 5-Fu 850mg/m\^2 d1-4 adjuvant chemotherapy were started at 21 days after surgery in patients with a successful conversion. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
RECRUITINGIncidence of translational treatment AE
Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned
Time frame: up to 2 years
MPR
The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy
Time frame: up to 2 years
pCR
Pathological complete response refers to that no tumor component or a small amount of carcinoma in situ component can be found on the horizontal line of pathological section after systemic treatment and surgical resection of the lesion.
Time frame: up to 2 years
R0 resection rate
The proportion of patients who completed R0 resection through 3 cycles of immunotherapy combined with chemotherapy in the total enrolled population.R0 finger resection margin under microscope was negative.
Time frame: up to 2 years
Disease-free Survival,DFS
The time from randomization to disease recurrence or death due to disease progression
Time frame: up to 2 years
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A FP regimen with 5-Fu 850mg/m\^2 d1-4 + cis-platinum 850mg/m\^2 d1-4 was used, on D1, D22 and D43 infused intravenously. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.