Malignant tumor of esophagus
Conditions
Interventions
Case series:Karelizumab combined with apatinib
Sponsors
Cancer Hospital Affiliated to Xinjiang Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Patients with advanced esophageal squamous cell carcinoma diagnosed by pathology. 2. Participate voluntarily, have good compliance, and can cooperate with the observation of the experiment, all subjects need to sign an Inform Consent Form (ICF) before starting the research related operations. 3. At least one measurable lesion, normal CT or MRI scan lesion >=20mm, spiral CT >=10mm. 4. Aged 18-74 years, with good physical condition, ECOG =3.0 x 10^9/L; absolute neutrophil count (ANC) >=1.5 x 10^9/L; platelet (PLT) >=100 x 109/L; hemoglobin content (hemoglobin, HGB) >=9.0 g/dL; (2) Liver function: aspartate transferase (AST) =3 g/dL; (3) Renal function: serum creatinine =40 mL/minute (using Cockcroft/Gault formula, refer to Appendix 2); urine protein (UPRO) is negative; (4) Coagulation function: international normalized ratio (INR) 1.5 x ULN has no clinical or imaging evidence of pancreatitis, it can be included in the group; amylase 1.5 x ULN has no clinical or imaging evidence of pancreatitis, it can be included in the group; Alkaline phosphatase (ALP)<=2.5ULN, subjects with bone metastases, ALP<=5ULN. 7. Male subjects and females of childbearing age must have contraception within 24 weeks after starting the first dose of study drug to the last study drug (refer to protocol 6.6.2 for recommended contraceptive methods).
Exclusion criteria
Exclusion criteria: 1. Active brain metastasis or meningeal metastasis. Treated subjects with brain metastases need to meet the following conditions before they can be included in the group: (1) No MRI-proven progress >= 4 weeks after the end of treatment; (2) Complete treatment within >=28 days before the first dose of study drug. 2. Active tuberculosis (tuberculosis, TB) or subjects with a history of active tuberculosis infection within 48 weeks before screening, regardless of treatment. 3. The recent use of hormone therapy. 4. Existing severe acute infections that have not been controlled; or have purulent and chronic infections, and the wounds are prolonged and unhealed. 5. Pre-existing severe heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction, severe heart valve disease and refractory hypertension; New York Heart Association grade >= II heart Functional insufficiency. 6. The number of neutrophils in peripheral blood is lower than 1500/mm^3. 7. Patients who suffer from uncontrollable neurological or mental illnesses or mental disorders, have poor compliance, and do not cooperate and describe treatment responses. 8. Pregnant and lactating women. 9. Patients with other uncured malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Disease control rate;Adverse reactions; | — |
Countries
China
Contacts
Public ContactTang Yong
Cancer Hospital Affiliated to Xinjiang Medical University
Outcome results
None listed