Advanced Adrenal Cortical Carcinoma
Conditions
Interventions
Control group:Mitotane
Test Group:Toripalimab combined with Mitotane
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients signed the informed consent; 2. Pathology diagnosed as adrenal cortical carcinoma; 3. ENSAT stage III-IV patients and unable to receive surgery; 4. Mitotane treated less than or equal to 8 weeks; 5. Not received systemic immunotherapy; 6. ECOG score: 0 to 1; 7. Child Pugh score =1.5×10^9/L, Platelet (PLT) >=70×10^9/L, Hemoglobin, (HGB)>=90g/L (2) Total Bilirubin (TBIL)= 28 g/L, Alkaline Phosphatase (ALP) = 50 mL/mi (4) International Normalized Ratio (INR) = 6 months;
Exclusion criteria
Exclusion criteria: 1. Previously or simultaneously suffering from other malignant tumors; 2. Previously received systemic immunotherapy; 3. Patients with history of allergies to large molecule protein preparations or drug used; 4. Patients with active autoimmune disease requiring systemic treatment (eg: using disease relieving drugs, corticosteroids, or immunosuppressants) within 2 years. Alternative therapies (eg: thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered as systemic treatments; 5. Patients using traditional Chinese medicine or other immune modulators within 2 weeks before enrollment; 6. Patients with ascites or pleural effusion with clinical symptoms cannot be controlled with medication and require therapeutic puncture or drainage; 7. Clinical symptoms or diseases of the heart that have not been well controlled, such as: NYHA grade 2 or above heart failure, Unstable angina pectoris, Have experienced myocardial infarction within one year, Patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 8. History of substance abuse, alcoholism, or drug use; 9. Pregnant or lactating women; 10. Men with reproductive ability or women with the possibility of pregnancy (referring to men or women who have not undergone contraceptive surgery, as well as women who have not gone through menopause) must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) during the trial, and continue contraception for 6 months after the last dose; 11. Patients that researchers believe that should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated midway, such as other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory abnormalities, accompanied by family or social factors that may affect the safety of the participants, or the collection of data and samples;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival rate;Overall survival;Disease control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression free survival;Safety; | — |
Countries
China
Contacts
Public ContactZhang Yushi
Peking Union Medical College Hospital
Outcome results
None listed