Evaluating the rate of pathologic complete remission in patients with squamous esophageal cancer treated perioperatively with tislelizumab in combination with chemotherapy
Subjects were enrolled in the study and signed an informed consent form.
Male or female patients between the ages of 18 and 75.
Patients with esophageal squamous carcinoma diagnosed by histopathology.
According to the TNM staging system of esophageal cancer in the 8th edition of the AJCC,the disease is in the stage of cT3-4aN0M0 or cT1b-4aN+M0 (confirmed by thoracic and abdominal enhancement CT/MRI), and the lesion is located in the thoracic segment.
The presence of clinically uncontrolled chest that required repeated drainage or medical intervention (within 2 weeks prior to randomization) Hydrocele, pericardial hydrocele or ascites;
Known intolerance or resistance to chemotherapy specified in the trial protocol;
Have received any other ESCC anti-tumor therapy (e.g., targeting PD-1, PD-L1, PD-L2) Or other tumor immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapy);
Patients who have an active autoimmune disease or have a history of an autoimmune disease but may relapse may have a known abnormality History of body organ transplantation or allogeneic hematopoietic stem cell transplantation;
Single group
Tislelizumab
DrugTislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
albumin-bound paclitaxel
Drugalbumin-bound paclitaxel 260mg/m2，day 1 of every 3 weeks
Nedaplatin
DrugNedaplatin 80mg/m2，day 1 of every 3 weeks
Pathological complete response rate
Pathological complete responseTotal tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Major pathological response rate
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Objective Response Rate
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
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