Tislelizumab combined with chemotherapy sequential neoadjuvant therapy for non-cCR patients after neoadjuvant chemoradiotherapy in locally advanced ESCC. And then the patients would receive surgery and adjuvant therapy according to the postoperative pathological results. It is expected that through this study, some high-risk patients could obtain better efficacy and prolong patient survival. At same time, low risk patients could avoid increasing perioperative complications and surgical risks, so that more patients could benefit from neoadjuvant treatment. The investigators aimed to explore a more accurate comprehensive treatment mode for patients with esophageal squamous cell carcinoma, and provide a certain scientific basis for the formulation of esophageal cancer diagnosis and treatment norms in China.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Two cycles of Tirelizumab (200mg administered as an intravenous infusion over 30 minutes per 3 weeks), D1.
Two cycles of paclitaxel (135mg/m2 administered as an intravenous infusion per 3 weeks), D1.
Two cycles of carboplatin(AUC=5 administered as an intravenous infusion per 3 weeks) D1.
Simultaneous radiotherapy would be consecutively performed for 4 weeks with the total dose of 40Gy (40Gy/ 4W /20F), D1.
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, China
Complete pathologic response rate
Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"
Time frame: 3 months
Incidence of adverse events
Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0
Time frame: 6 months
Clinical Complete Remission
The clinical complete remission rate (cCR) was defined as the proportion of patients with clinically confirmed cT0 or cN0(AJCC Cancer Staging Manual,8th ed. 2017 edition ).
Time frame: 3 months
Major Pathological Remission rate
The residual tumor after neoadjuvant treatment ≤ 10% residual tumor lesion in surgical specimen compared to baseline。
Time frame: 3 months
Objective Remission Rate
Objective response rate as assessed by RECISIST1.1 criteria, the percentage of subjects with CR or PR in the total number of subjects in the analysis data set during the period from the beginning of the treatment regimen to the disease progression date.
Time frame: 3 months
Rate of R0 resection
Measure the rate of R0 resection with all margins microscopically clear.
Time frame: 3 months
Events Free Survival
Event-free survival was defined as the time from the date of randomization to the date of the first documented non-fatal event (worsening cardiac function, hospitalization for congestive heart failure, liver function impairment, liver cirrhosis, transformation to AML, as defined in the protocol), or death, whichever occurred first. Participants who did not experience a non-fatal event as of the time of data cut-off (end of study), as well as participants who did not experience a non-fatal event and stopped study participation before the data cut-off, were censored as specified in the protocol.
Time frame: Through study completion, an average of 1 year.
Overall Survival
Overall survival was the duration from the start of study treatment to death
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
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