Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer

• Status: Recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

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 infarction, unstable or severe angina, coronary artery bypass surgery, congestive heart failure, and room requiring medical intervention within the first 6 months of enrollment arrhythmia, left ventricular ejection fraction <50%

• severe allergies

• severe mental disorder

• abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy

• previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc

• other situations evaluated by investigators not meet the enrollment