Status:
RECRUITING
Neo-adjuvant Immunochemotheray Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Carcinoma
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Esophageal Cancer
Surgery
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The effect of neo-adjuvant immunochemotherapy on survival of patients with thoracic esophageal squamous cell carcinomas remains unknown. One of our objectives is to evaluate whether the neo-adjuvant i...
Detailed Description
The effect of immunochemotherapy in second line treatment of esophageal cancer got a positive results in the world. We tried to apply the immunotheray in resectable esophageal cancer and have planed t...
Eligibility Criteria
Inclusion
- 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).
- No metastatic lymph node in cervical by color doppler sonography.
- Patients must not have received any prior anticancer therapy of esophageal carcinoma.
- Age ranges from 18 to 75 years.
- Without operative contraindication.
- 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.
- 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).
- expected R0 resection.
- ECOG 0～1.
- 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.
- Signed informed consent document on file. 10. .
Exclusion
- 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.
- Pregnant or breast feeding 10.Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.
- 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。
Key Trial Info
Start Date :
April 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 2 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04280822
Start Date
April 21 2020
End Date
March 2 2028
Last Update
October 4 2022
Active Locations (1)
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1
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, China, 450003