recurrent or metastatic adrenocortical carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of adrenocortical carcinoma; 2. Patients with metastatic or inoperable adrenocortical carcinoma that has progressed, metastasized, or recurred after first line standard treatment (mitotane monotherapy, chemotherapy alone, mitotane combined chemotherapy); 3. Aged >=18 years; 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 5. At least one measurable lesion, according to RECIST 1.1; 6. Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion): HB>=80g/L, ANC>=1.5x10^9/L, PLT >=80x10^9/L; TBIL=60ml/min; INR or PT <=1.5 ULN, APTT <=1.5 ULN (if the patient is receiving anticoagulant therapy, PT and APTT should be within the expected treatment range); 7. Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment; 8. Have signed consent form.
Exclusion criteria
Exclusion criteria: 1. History of prior malignancy, except for cured in situ cervical carcinoma and cured non-melanoma skin cancer; 2. Central nervous system metastasis with symptoms; 3. Active autoimmune disease; 4. Poor control of high blood pressure(SBP>=150mmHg or DBP>=90mmHg); 5. Ischemic cardiovascular events occurred within 1 year prior to the start of treatment; 6. Congestive heart failure of New York Heart Association (NYHA) Class III or IV; 7. Patients are receiving immunosuppressive therapy; 8. Thromboembolic events occurred within 6 months prior to the start of treatment; 9. ECG QT interval >500ms; 10. Patients with symptoms of gastrointestinal bleeding or risk of bleeding; 11. Active infection, or patients are pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival;Overall Survival;Adverse Events; | — |
Countries
China
Contacts
West China Hospital, Sichuan University