Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma

Inclusion criteria

• Histologically confirmed diagnosis of adrenocortical carcinoma;
• 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);
• Aged >=18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• At least one measurable lesion, according to RECIST 1.1;
• 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≤1.5 ULN, ALT and AST ≤2.5 ULN, if there exists hepatic metastases, ALT and AST ≤5 ULN, Cr ≤1.5 ULN or CCr ≥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); Cardiac Markers and BNP≤ULN；TSH≤ULN (If TSH is abnormal, T3 and T4 should be normal)
• Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment;
• Have signed consent form.

Exclusion criteria

• Patients with another primary malignancy within 5 years prior to starting the study drug, except for cured in situ cervical carcinoma and cured non-melanoma skin cancer;
• Have central nervous system metastasis with symptoms and need hormonal intervention;
• Had received strong CYP3A4 inhibitors within one week prior to enrollment or received strong CYP3A4 inducers within two weeks prior to enrollment;
• Poor control of high blood pressure (SBP>140mmHg or DBP>90mmHg);
• Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
• Thromboembolic events occurred within 1 year prior to enrollment;
• ECG QT interval >500ms;
• Previous systemic immunosuppressive therapy;
• Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment;
• Received TKI treatment within 2 weeks prior to starting the study drug;
• Participate in clinical trials of other interventional drugs within 4 weeks prior to starting the study drug;
• Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug;
• An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the study drug;
• Major surgery or severe trauma within 4 weeks prior to starting the study drug;
• Severe infections occurred within 4 weeks prior to starting the study drug;
• Have an active autoimmune disease or a history of autoimmune diseases;
• Have a history of immunodeficiency;
• Have an active tuberculosis infection;
• Have active hepatitis;
• Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
• Active infection, or patients are pregnant or breast-feeding.