Esophageal squamous carcinoma
Conditions
Interventions
Intervention group: Toripalimab combined with paclitaxel and platinum as neoadjuvant therapy
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age is 18-75 years old, both male and female; 2. Patients with resectable ct2-t3 / N0-N1 / M0 esophageal squamous cell carcinoma diagnosed by histology or cytology for the first time; 3. Patients who have not received any systematic anti-tumor treatment before; 4. Patients with ECoG score of 0-1; 5. The functions of important organs meet the following requirements: The absolute neutrophil count was more than 1.5 * 10^9 / L; Platelet >= 80 * 10^9 / L; Hemoglobin >= 80 * 10^9 / L; Total bilirubin <= 1.5 upper limit of normal value; Serum creatinine was within normal value; Alanine aminotransferase and aspartate aminotransferase <= 2.5 upper limit of normal value; There were no serious complications or other major diseases that had not been cured in the past; 6. The patients who can tolerate surgery judged by thoracic surgeons; 7. Fertile female subjects and male subjects with partners of childbearing age need to use a medically approved contraceptive method during the study treatment and at least 6 months after the last treatment; 8. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with BMI = 10% in two months before screening (at the same time, the influence of a large number of pleural effusion and ascites on body weight should be considered); 2. Patients with gastrointestinal perforation and / or fistula history within 6 months before the first medication; 3. Known to be allergic or hypersensitive to any component of biopharmaceuticals produced by Chinese hamster ovary cells (CHO) or PD-1 monoclonal antibody preparation; 4. Subjects with allergic history to paclitaxel, albumin paclitaxel, carboplatin and other platinum drugs; 5. Have received any of the following treatments: (1) He had received anti-PD-1 or PD-L1 antibody treatment. (2) Any study drug was received within 4 weeks before the first use of the study drug. (3) At the same time, they were enrolled in another clinical study, unless it was an observational (non intervention) clinical study or an intervention clinical study follow-up. (4) Received the last dose of anti-cancer treatment (including radiotherapy, etc.) within 4 weeks before the first use of the study drug. (5) Subjects requiring systematic treatment with corticosteroids (equivalent to 10 mg prednisone per day) or immunosuppressive agents within 2 weeks before the first use of the study drug were excluded from the use of cortical sterols for local esophageal inflammation and prevention of allergy, nausea and vomiting. Other special circumstances, need to communicate with the sponsor. In the absence of active autoimmune diseases, topical or inhaled steroids are permitted. If patients need to take immunosuppressive drugs accidentally during the trial, they will be allowed, but it is strongly recommended that the dosage be reduced as soon as possible. (6) Those who have received anti-tumor vaccine or received live vaccine within 4 weeks before the first administration of the study drug. 6. Patients with active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except vitiligo or recovered childhood asthma / allergy without any intervention in adulthood Patients with type 1 diabetes mellitus (type 1 diabetic patients whose blood sugar can be controlled after treatment with a stable dose of insulin can be included in this study); 7. Patients with a history of immunodeficiency, including HIV positive, other acquired and congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; 8. Subjects had cardiovascular clinical symptoms or diseases that could not be well controlled, including but not limited to: 1. NYHA grade II or above heart failure. 2. Unstable angina pectoris. 3. Myocardial infarction occurred within 1 year. 4. Supraventricular or ventricular arrhythmias with clinical significance are still poorly controlled without clinical intervention or after clinical intervention. 9. Active hepatitis B [chronic or acute patients; defined as positive HBsAg test results and HBV DNA copy number > 1000cps / ml] or hepatitis C patients: 10. Patients with active tuberculosis (clinical diagnosis includes clinical history, physical examination and imaging findings, and TB examination according to local medical practice). 11. Patients with severe infection (CTCAE > Level 2) within 4 weeks before the first use of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response (PCR);major pathologic response (MPR).; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Disease-free survival (DFS);Overall survival (OS);safety;objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactMengxia Li
Department of Oncology, Army Characteristic Medical Center
Outcome results
None listed