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

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 followingcriteria(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 thepatient is receiving anticoagulant therapy, PT and APTT should be within theexpected treatment range); Cardiac Markers and BNP≤ULN；TSH≤ULN (If TSH is abnormal,T3 and T4 should be normal)

7. Appropriate contraception should be used from the start of treatment to 120 daysafter the end of treatment;

8. Have signed consent form.

Exclusion Criteria:

1. Patients with another primary malignancy within 5 years prior to starting the studydrug, except for cured in situ cervical carcinoma and cured non-melanoma skincancer;

2. Have central nervous system metastasis with symptoms and need hormonal intervention;

3. Had received strong CYP3A4 inhibitors within one week prior to enrollment orreceived strong CYP3A4 inducers within two weeks prior to enrollment;

4. Poor control of high blood pressure (SBP>140mmHg or DBP>90mmHg);

5. Congestive heart failure of New York Heart Association (NYHA) Class III or IV;

6. Thromboembolic events occurred within 1 year prior to enrollment;

7. ECG QT interval >500ms;

8. Previous systemic immunosuppressive therapy;

9. Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment;

10. Received TKI treatment within 2 weeks prior to starting the study drug;

11. Participate in clinical trials of other interventional drugs within 4 weeks prior tostarting the study drug;

12. Received systemic therapy with corticosteroids or other immunosuppressants within 2weeks prior to starting the study drug;

13. An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to startingthe study drug;

14. Major surgery or severe trauma within 4 weeks prior to starting the study drug;

15. Severe infections occurred within 4 weeks prior to starting the study drug;

16. Have an active autoimmune disease or a history of autoimmune diseases;

17. Have a history of immunodeficiency;

18. Have an active tuberculosis infection;

19. Have active hepatitis;

20. Patients with symptoms of gastrointestinal bleeding or risk of bleeding;

21. Active infection, or patients are pregnant or breast-feeding.