Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer (NCT03985670) | Clinical Trial Compass
UnknownPhase 2
Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer
China30 participantsStarted 2019-07-10
Plain-language summary
The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Thoracic esophageal squamous cell carcinoma diagnosed by pathology
* no distant metastasis, the diseases could be resected or potentially resectable assessed by thoracic oncologist
* ECOG score 0-1
* clinical stage is stage II, III, and IVa according to AJCC 8.0
* expected lifespan \> 3 months
* enough organ function
* normal blood pressure, for patients with hypertension, the blood pressure should be controlled in normal level by antihypertension
* the fasting blood sugar should be ≤ 8mmol / L for diabetic patients
* no other serious diseases (such as autoimmune diseases, immunodeficiencies, organ transplants) that conflict with this study
* no history of other malignant tumors
* women of childbearing period must be tested negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the trial period and within 6 months after the trial;
* The patient agrees to participate in the clinical study and sign the Informed Consent Form.
Exclusion Criteria:
* suffering from serious infectious diseases within 4 weeks before enrollment;
* patients with bronchial asthma requires intermittent use of bronchodilators or medical interventions;
* usage of immunosuppressants before the enrollment, the amount of immunosuppressant used ≥10mg / day oral prednisone for more than 2 weeks
* clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial…