Esophagus Cancer
Conditions
Brief summary
Evaluating the rate of pathologic complete remission in patients with squamous esophageal cancer treated perioperatively with tislelizumab in combination with chemotherapy
Interventions
DRUGTislelizumab
Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
DRUGalbumin-bound paclitaxel
albumin-bound paclitaxel 260mg/m2，day 1 of every 3 weeks
DRUGNedaplatin
Nedaplatin 80mg/m2，day 1 of every 3 weeks
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * ECOG score: 0-1. * Normal functioning of major organs, i.e. meeting the following criteria. 1. Blood count (no blood transfusions, granulocyte colony-stimulating factor \[G-CSF\], or other medications corrected within 14 days prior to treatment); and Absolute neutrophil count (ANC) ≥1.5×109/L; hemoglobin (HB) ≥9.0 g/dL; and Platelet count (PLT) ≥ 100 x 109/L; 2. blood biochemistry Creatinine clearance ≥60 mL/min. Total bilirubin (TBIL) ≤ 1.5 x ULN. Albuminous aminotransferase (AST) or albuminous aminotransferase (ALT) levels ≤ 2.5 x ULN; * Expected survival \> 6 months. * Female subjects of childbearing potential and male subjects with partners of childbearing potential are required to use a medically approved contraceptive method during study treatment and for at least 6 months after the last treatment.
Exclusion criteria
* 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; * A history of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease, including pulmonary fibrosis, Acute lung disease; * There were severe chronic or active patients requiring systemic antimicrobial therapy, antifungal therapy or antiviral therapy before enrollment Infection (including tuberculosis infection, etc.); * Have a known history of HIV infection; * The presence of any serious or uncontrolled systemic disease, including but not limited to: Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure; Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, cerebrovascular accident, or transient ischemic attack, during the 6 months prior to the first dose of the study; Uncontrolled hypertension (i.e., ≥ CTC-AE level 2 hypertension after medication); active pulmonary tuberculosis; those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; * Had other malignancies in the past 5 years (cured skin basal cell carcinoma, breast carcinoma in situ and Except primary cervical cancer); * Had received live vaccine within 28 days prior to enrollment; * Have participated in other therapeutic clinical trials within 4 weeks; * And those deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response rate | 4 weeks after surgery | Pathological complete responseTotal tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response rate | 4 weeks after surgery | Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell |
| Objective Response Rate | At the end of Cycle 2(each cycle is 28 days) | Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor |
Contacts
Primary ContactGeng guo jun, Doctor
Outcome results
None listed