adrenocortical carcinoma
Conditions
Interventions
Case series:N/A
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The inclusion criteria for patients are as follows: 1. Histopathological diagnosis of adrenocortical carcinoma. 2. Patients with adrenocortical carcinoma who are currently receiving or about to start monotherapy with mitotane. 3. Age = 18 years. 4. ECOG performance status score of 0-1. 5. No significant liver or kidney dysfunction. Biochemical tests should meet the following criteria: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3.5×ULN. If liver metastasis is present, ALT and AST = 5×ULN. Serum creatinine (Cr) = 1.5×ULN and/or creatinine clearance (CCr) = 40 ml/min. 6. Women of childbearing potential must agree to use contraception (such as intrauterine devices, contraceptive pills, or condoms) during the study and for 120 days after the study. Serum or urine pregnancy tests must be negative within 7 days prior to enrollment, and the patient must not be lactating. Male patients must agree to use contraception during the study and for 6 months after the study. 7. Willingness and ability to comply with the planned visits, study treatments, laboratory tests, and other study procedures, as confirmed by the informed consent form signed by the patient.
Exclusion criteria
Exclusion criteria: Patients cannot be included if they meet any of the following criteria: 1. History of any other malignant tumor within the past 5 years and currently undergoing systemic antitumor treatment, with the exception of cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma. 2. Received any cytotoxic chemotherapy, radiation therapy, targeted therapy, biologic therapy (tumor vaccines, cytokines, or growth factor inhibitors), antitumor herbal therapy (Chinese herbal medicine with clearly defined indications for antitumor use, such as Compound Venenum Bufonis Capsules), or any other investigational anticancer drug therapy (defined as a treatment currently not approved by regulatory authorities) within 4 weeks prior to screening. 3. History of immune deficiency, including HIV-positive status, other acquired or congenital immunodeficiency diseases, organ transplantation, or bone marrow transplantation. 4. Active hepatitis B (HBV DNA = 2000 IU/ml or 10,000 copies/ml) or hepatitis C (positive HCV antibodies and HCV-RNA higher than the detection limit of the assay). 5. Known history of substance abuse, alcoholism, or drug addiction. 6. History of severe mental disorders. 7. Currently pregnant or breastfeeding. 8. Participation in any clinical trial within the previous 3 months. 9. Presence of medical history, disease, treatment, or laboratory abnormalities that may interfere with the study results or hinder the subject's full participation in the study, or when the investigator believes that participation in the study is not in the best interest of the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood concentration of Mitotane; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hormone levels; | — |
Countries
China
Contacts
Public ContactLi Zheng
West China Hospital of Sichuan University
Outcome results
None listed