esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Camrelizumab 200mg+ S-1 or 5-Fu Q3W 4-6 cycles, Camrelizumab was maintained for no more than 2 years
Sponsors
Affiliated Hospital of Yangzhou University
Eligibility
Sex/Gender
All
Age
75 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged >= 75 years; 2. Histologically confirmed primary esophageal squamous cell carcinoma, unresectable locally advanced/distant metastatic esophageal cancer confirmed by pathology and imaging, stage IV; 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 other than surgery 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: (1) Hemoglobin >= 90 g/L (no blood transfusion within 14 days); (2) Neutrophil count > 1.5x10^9/L; (3) Platelet count >= 100x10^9/L; (4) Total bilirubin = 60 mL/min (Cockcroft-Gault formula); (8) 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. (1) 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) ); (2) Non-surgical sterilized female subjects of childbearing age must have negative serum or urine HCG tests within 7 days before study enrollment, and must be non-lactating; (3) Male subjects of non-surgical sterilization or of childbearing age need to agree to use a medically approved contraceptive method with their spouses during the study treatment period and within 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 who have previously received radiotherapy, chemotherapy, targeted therapy, and immunotherapy for primary esophageal squamous cell carcinoma; 2. Subject has previous or co-existing malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 3. Participated in clinical trials of other drugs within 4 weeks; 4. Screening subjects with known CNS metastases or a history of CNS metastases. For the subjects suspected of central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis. 5. Patients newly diagnosed with angina pectoris within 3 months prior to screening or patients with myocardial infarction within 6 months prior to screening; Arrhythmias (including QTcF: >=450 ms for men and >=470 ms for women) requiring long-term use of antiarrhythmic drugs and New York Heart Association classification >=II cardiac insufficiency; 6. The subjects present (within 3 months) with esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension and other gastrointestinal diseases, or with active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; 7. There is a history of bleeding, and any bleeding event with severity grade 3 or above in CTCAE 5.0 occurred within 4 weeks prior to screening; 8. Patients with abnormal coagulation function and bleeding tendency (INR must be within the normal range without the use of anticoagulants 14 days before randomization); Subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analoges; The use of low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (not more than 100 mg daily) for preventive purposes is permitted if the international standardized ratio of prothrombin time (INR) <= 1.5; 9. A history of immunodeficiency, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 10. Subjects with past or present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 11. Have a history of severe chronic autoimmune diseases, such as systemic lupus erythematosus; A history of ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases, and a history of chronic diarrheal diseases such as irritable bowel syndrome; A history of sarcoidosis or tuberculosis; 12. Subjects with high sensitivity to human or mouse monoclonal antibodies; 13. Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders; 14. Pleural or abdominal effusion with clinical symptoms requiring clinical intervention; 15. Subjects who do not follow the doctor's advice, do not follow the prescribed medication, or have incomplete information that may affect the judgment of efficacy or safety; 16. Concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subject or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactChen Yong
Affiliated Hospital of Yangzhou University
Outcome results
None listed