Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:tislelizumab: 200 mg intravenous infusion, D1, Q3W
nab-paclitaxel: 260 mg/m2 intravenously, D1, Q3W
Cisplatin: 70 mg/m2 intravenous infusion, D1, Q3W
Control group:nab-paclitaxel: 260 mg/m2 intravenously, D1, Q3W
fluorouracil: 750 mg/m2 intravenous infusion, D1-D5, Q3W
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old= age = 75 years old, male or female; 2. Stage II-III squamous cell carcinoma (as defined by AJCC 8th edition) with a clear diagnosis of pathological type by gastroscopic biopsy; 3. The primary tumor is located in the chest, and the primary site of esophageal cancer is determined by the position of the esophagus where the upper edge of the mass is located (upper thoracic esophagus: from the thoracic inlet to the level of the lower edge of the azygous vein arch, and the endoscopic examination is 20 cm to <25 cm from the incisors; Middle thoracic esophagus: ascending from the inferior border of the azygous vein arch to the level of the inferior pulmonary vein, 25 cm to 30 cm < the incisors on endoscopy; Lower thoracic esophagus: up from the level of the lower pulmonary veins to the lower stomach, endoscopy from the incisors 30 cm to <40 cm); 4. At least one measurable lesion (criteria RECIST1.1); 5. Eastern Cooperative Oncology Group Physical State Score (ECOG PS) 0~1 points; 6 Expected survival= 12 months; 7. Newly diagnosed patients who have not undergone surgery, chemoradiotherapy, targeted therapy or immunotherapy; 8. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment. Male subjects, as well as females of childbearing potential, must be contraceptive from initiation of the first dose of study drug to 24 weeks after the last dose of study drug; 9. The laboratory test values of patients before medication should meet the following criteria: 1) Blood routine: WBC =3.0 × 109/L; ANC=1.5 × 109/L; PLT=100 × 109/L; HGB=9.0 g/dL 2) Liver function: AST=2.5 × ULN, ALT=2.5 × ULN, TBIL =1.5 × ULN 3) Renal function: Cr=1.5 × ULN or CrCl =50 mL/min 4) Coagulation function: INR=1.5, APTT=1.5×ULN; 10. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Histological or cytological pathology of the tumor confirmed as esophageal adenocarcinoma; 2. Prior receipt of any T cell co-stimulation or immune checkpoint therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs targeting T cells; 3. Previous or current history of other cancers other than esophageal cancer, except for non-melanoma skin cancer, cervical cancer in situ, or other cancers that have received curative treatment and have no signs of recurrence for at least 5 years; 4. Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid treatment or clinically symptomatic active pneumonitis or severe pulmonary dysfunction; 5. Hypertension that has not been controlled with standard treatment (blood pressure is not stable below grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc., requiring hospitalization; 9. Patients with clinically uncontrollable third space effusion (such as pleural effusion/pericardial effusion, patients who do not need to drain the effusion or who do not have a significant increase in the effusion after stopping drainage for 3 days can be enrolled); 10. Those whose imaging (CT or MRI) shows that the tumor has invaded the large blood vessels, or the investigator judges that the tumor is very likely to invade important blood vessels during the follow-up study, causing fatal hemorrhage; 11. Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 12. Patients with active hepatitis B (defined as a positive test result for hepatitis B virus surface antigen [HBsAg] during the screening period and a detection of HBV-DNA test value higher than the upper limit of normal in the laboratory department of the research center) or hepatitis C (defined as a positive test result for hepatitis C virus surface antibody [HCsAb] and HCV-RNA positive during the screening period); 13. Those who have an allergic reaction to the test drug of this application; 14. In the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathologic Response;Progression-Free Survival;R0 resection rate;Objective Response Rate ;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactWenshu chen
Fujian Provincial Hospital
Outcome results
None listed