Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma

Launched by HENAN CANCER HOSPITAL · Feb 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a specific type of esophageal cancer, called thoracic esophageal squamous cell carcinoma. Researchers want to find out if a combination of immunotherapy (using a drug called Toripalimab) and chemotherapy (cisplatin and paclitaxel) before surgery can help patients live longer compared to just chemotherapy before surgery. The goal is to see if this new treatment can improve survival rates for patients who are eligible for surgery to remove the cancer.

To participate in this trial, patients must be between 18 and 75 years old and have a confirmed diagnosis of local advanced esophageal cancer that has not spread to other areas of the body. They should not have received any previous cancer treatments and must meet certain health criteria, such as having normal blood counts and organ functions. If you or someone you know is considering this trial, participants can expect to receive the study treatment and undergo surgery, while closely monitored by healthcare professionals throughout the process. It's important to discuss any potential concerns or questions with a doctor before joining the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologic diagnosis of local advance squamous cell thoracic esophageal carcinoma of Stage (T1N1-3 or T2-3N0-3 M0), (8th Union for International Cancer Control, UICC-TNM).
• • 2. No metastatic lymph node in cervical by color doppler sonography.
• • 3. Patients must not have received any prior anticancer therapy of esophageal carcinoma.
• • 4. Age ranges from 18 to 75 years.
• • 5. Without operative contraindication.
• • 6. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
• • 7. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).
• • 8. expected R0 resection.
• • 9. ECOG 0～1.
• • 10. Patients should agree to use contraceptive measures during the study period and within 6 months of the end of the study. Women must be non-lactation.
• • 11. Signed informed consent document on file. 10. .
• Exclusion Criteria:
• • 1. Multiple primary cancer. 2.Patients with infections disease that require treatment 3.Patients who need continuous hormone treatment 4.unstable angina within 3 months, myocardial infarction within 6 months 5.psychopath 6.Patients with concomitant hemorrhagic disease. 7.Any unexpected reason for patients can't get operation 8.Inability to use gastric conduit after esophagectomy because of a prior surgery.
• • 9.Pregnant or breast feeding 10.Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.
• • 11.Bronchial asthma who requires intermittent use of bronchodilators or medical interventions 12.Due to co-existing diseases, the immunosuppressant was used. And the dosage of immunosuppressant was more than 10mg/ day orally and more than 2 weeks before enrollment 13.Abnormal coagulation function (PT\>16s, APTT\>53s, TT\>21s, Fib\<1.5g/L), tendency of bleeding or receiving thrombolysis or anticoagulant therapy 14.Previous or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, lung function severely impaired 15.Autoimmune diseases, immune deficiency, organ transplantation； 16.Hepatitis b/c patients。