Esophageal cancer
Conditions
Interventions
Experimental group:Relizumab combined with concurrent radiotherapy and chemotherapy
Sponsors
Pingdingshan First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limits; 2. Histologically confirmed as esophageal squamous cell carcinoma; 3. Patients with locally advanced esophageal cancer; 4. ECOG:0-2; 5. Expected survival period >= 12 weeks; 6. The main organs are functioning normally, that is, they meet the following standards: (1) Routine blood examination: HB >= 90g/L, b.ANC >= 1.5 x 10^9/L, c.PLT >= 80x10^9/L; (2) Biochemical inspection: ALB >= 30g/L, ALT and AST <= 2.5ULN, if there is liver metastasis, ALT and AST <= 5ULN; c.TBIL <= 1.5ULN; 7. Females of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study, serum or urine pregnancy tests are negative within 7 days before study entry, and must be a non-lactating patient,and men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 8. The patients voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Allergic or metabolic disorder to capecitabine and karelizumab; 2. Patients with any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma in childhood has been completely alleviated, adults do not need any intervention can be included; patients with vitiligo should be included Asthma that needs medical intervention with bronchodilators cannot be included; 3. The patient is using immunosuppressant or systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones), and continues to use it within 2 weeks before entering the group; 4. Contraindications of radiotherapy; 5. Active or uncontrolled severe infection; 6. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA >= 104 copies / ml or 2000iu / ml) or hepatitis C (HCV antibody positive and HCV-RNA higher than the analyzers) 7. The patients whose imaging showed that the tumor had invaded the important blood vessels or the tumor was likely to invade the important blood vessels during the follow-up study; 8. Pregnant or lactating women; 9. Patients with other malignant tumors within 10.5 years (except for cured basal cell carcinoma of skin and carcinoma in situ of cervix); 10. Patients who have a history of psychotropic drug abuse and can not give up or have mental disorders; 11. Patients who have participated in clinical trials of other drugs within four weeks; 12. According to the judgment of the researcher, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 13. The researchers think that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Safety; | — |
Countries
China
Contacts
Public ContactJing Xiaohui
Pingdingshan First People's Hospital
Outcome results
None listed