esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Sequential concurrent chemoradiotherapy with camrelizumab
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years (including 18 and 75); 2. Histologically confirmed primary esophageal squamous cell carcinoma, pathologically and imaging-confirmed unresectable locally advanced esophageal cancer, stage T3-4N0M0, T1-4N+M0, stage II-IVa, AJCC 2017 clinical stage of esophageal squamous cell carcinoma; 3. At least one measurable lesion, according to RECIST 1.1 criteria; 4. Have not received local and systemic systemic therapy for primary esophageal squamous cell carcinoma before; 5. Physical condition score (ECOG PS score): 0-1 points; 6. Expected survival period >= 6 months; 7. The function of main organs is good, that is, the relevant inspection indicators within 14 days before enrollment meet the following requirements: hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count> 1.5 x 10^9/L; platelet count >= 100x10^9/L; total bilirubin = 60 mL/min (Cockcroft-Gault formula); cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 8. Thyroid function indicators: Thyroid-stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range or mild and no clinically significant abnormalities; 9. Non-surgical sterilization or female subjects of childbearing age who need to use a medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; non-surgically sterilized female subjects of childbearing age must have a negative serum or urine HCG test within 7 days prior to study enrollment; and must be non-lactating; non-surgical sterilization or male subjects of childbearing age need to agree to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period; 10. The subjects voluntarily joined the study, with good compliance, and with follow-up for safety and survival.
Exclusion criteria
Exclusion criteria: 1. Subjects with distant metastasis confirmed by imaging; 2. The subject has previously or concurrently suffered from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 3. Participated in clinical trials of other drugs within four weeks; 4. Subjects known to have central nervous system metastases or a history of central nervous system metastases before screening. For subjects with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; 5. Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmia (including QTcF: >= 450 ms for men, >= 470 ms for women) requires long-term use of antiarrhythmic drugs and New York Heart Association classification >= grade II cardiac insufficiency; 6. The subject currently (within 3 months) has esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases or active bleeding from unresectable tumors, or other conditions that may cause gastrointestinal bleeding and perforation as determined by the investigator; 7. There is a history of bleeding, and any bleeding event with a severe grade of grade 3 or above in CTCAE 5.0 occurs within 4 weeks before screening; 8. Abnormal coagulation function and bleeding tendency (must be satisfied 14 days before randomization: the INR is within the normal range without the use of anticoagulants); subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogs; on the premise of prothrombin time international normalized ratio (INR) <= 1.5, low-dose warfarin (1 mg orally, once a day) or low-dose aspirin (no more than 100 mg per day) is allowed for prophylaxis; 9. Have a history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10. Subjects with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired lung function, etc.; 11. Have a history of severe chronic autoimmune diseases, such as systemic lupus erythematosus, etc.; have a history of ulcerative colitis, Crohn's disease and other inflammatory bowel diseases, with history of chronic diarrheal diseases such as irritable bowel syndrome; history of sarcoidosis or tuberculosis; 12. Subjects with hypersensitivity to human or murine monoclonal antibodies; 13. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 14. Pleural effusion or ascites with clinical symptoms that require clinical intervention; 15. Subjects with incomplete data that may affect the judgment of efficacy or safety; 16. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactGe Xiaolin
Outcome results
None listed