Eesophageal Cancer
Conditions
Interventions
Test Group:Camrelizumab (200 mg/time, Q3W)
Apatinib mesylate 250 mg, qd continuous oral administration.
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up; 2. Aged 18-75 years, including 18 and 75 years, both male and female; 3. Diagnosed as ovarian cancer by pathological examination; 4. Those who have relapsed after using platinum drugs in the past, and the relapse interval is less than 6 months; 5. Physical fitness score ECOG 0-1; 6. According to the curative effect evaluation criteria for solid tumors (RECIST1.1), there is at least one measurable lesion; 7. Expected survival period >= 3 months; 8. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency; 9. Neutrophils >= 1.5 x 10^9/L; hemoglobin >= 9g/dL; platelets >= 100 x 10^9/L; total bilirubin <= 1.5 times the upper limit of normal; AST (SGOT) and ALT (SGPT) <= 2.5 times Upper limit of normal value; creatinine <= 1.5 times the upper limit of normal value.
Exclusion criteria
Exclusion criteria: 1. Suffer from any active autoimmune disease or have a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormonal After the replacement therapy is effective, it can be included), etc.) and have a history of using immunosuppressive agents within 28 days, except for the use of hormones to deal with the toxicity of radiotherapy and chemotherapy; 2. Adverse events greater than grade 2 caused by the treatment received before the first use of the study drug have not yet recovered (that is, grade 1 or reach the baseline level). According to the judgment of the investigator, adverse events that are difficult to recover quickly (such as neurotoxicity) can be included in the group 3. According to the judgment of the investigator, non-infectious pneumonia caused by previous radiotherapy and chemotherapy still exists; 4. Have received or are receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; 5. Known to be allergic to macromolecular protein preparations, or to any carrelizumab and its ingredients; 6. Suffer from uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure above NYHA II; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinical significance Supraventricular or ventricular arrhythmia in patients requiring clinical intervention; 7. Suffer from congenital or acquired immune function defects (such as HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method) Or active tuberculosis; 8. Active infection or fever of unknown cause occurred within 2 weeks before enrollment> 38.5 degrees C (according to the judgment of the investigator, the subject can be enrolled in the group for fever caused by tumor); 9. Reproductive men or women are unwilling to take contraceptive measures in the trial, and female patients are pregnant or breast-feeding; 10. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, family or social factors, which may affect the safety of the subject Or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR; | — |
Countries
China
Contacts
Public ContactHan Zhengxiang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed