Esophageal squamous cell carcinoma
Conditions
Interventions
single arm:PD-1 antibody
Paclitaxel combined with cisplatin chemotherapy
Radical resection of esophageal cancer through two incisions of right thoracic and upper abdomen.
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, both male and female. 2. Surgically resectable T2,3N0-1-2M0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology. 3. Not received any systematic anti-tumor treatment before. 4. ECOG0 is 0-1. 5. The functions of vital organs meet the following requirements: 5.1 Absolute neutrophil count>=2.0x10^9/L; 5.2 Platelet>=100x10^9/L; 5.3 Hemoglobin>=90x10^9/L; 5.4 Total bilirubin<=1.5 ULN; 5.5 Serum creatinine within normal value; 5.6 Glutamic-pyruvic transaminase, glutamic-oxaloacetic transaminase<=2.5 ULN; 5.7 No pre-existing serious complications or other major diseases that have not been cured; 6. Patients judged by the thoracic surgeon to be able to tolerate the surgery; 7. Fertile female subjects and Male subjects whose partners are of reproductive age will be required to use a medically approved contraceptive during the study treatment and at least 60 days after the last chemotherapy; 8. Subjects joined the study voluntarily and signed the informed consent. They should have good compliance and could cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Has received any of the following treatments: 1.1 Received any systemic antineoplastic treatment before the first use of the study drug; 1.2 Included in another clinical study at the same time, unless it is an observational (non-interventional) clinical study; 1.3 Subjects requiring systemic treatment with corticosteroids (more than 10mg prednisone equivalent daily) or other immunosuppressive agents within two weeks before the first use of the study drug; 1.4 Vaccinated with a tumor vaccine or vaccinated live vaccine within four weeks before administration; 2. With active autoimmune diseases and a history of autoimmune diseases; patients who have recovered from childhood asthma/allergy and need no intervention in adulthood; autoimmune mediated hypothyroidism treated with a stable dose of thyroid replacement hormone; Type I diabetes with a steady dose of insulin; 3. Experienced severe disturbance within 4 weeks before the first use of the study drug (CTC AE> level 2); baseline chest imaging revealed active pulmonary inflammation, present signs and symptoms of infection 2 weeks before the first use of the study drug or require oral or intravenous antibiotic treatment; 4. With a history of interstitial lung disease; 5. The subjects had active hepatitis B (HBV DNA>=2000IU/ml or 104copies/ml) and hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the lower limit of the analysis method). 6. Pregnant or lactating women; 7. Subjects with severe complications or other major diseases that have not been cured in the past; 8. Patients who cannot tolerate surgery as determined by the thoracic surgeon.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;R0 resection rate;overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Feasibility of Combined Therapy;three-year DFS rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactGuochun Cao
Medical oncology, Jiangsu Cancer Hospital
Outcome results
None listed