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

Launched by WEST CHINA HOSPITAL · Mar 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a rare and aggressive cancer called adrenocortical carcinoma (ACC), which is a type of tumor that affects the adrenal glands. The trial is testing a combination of two medications: camrelizumab, which helps the immune system fight cancer, and apatinib, which targets blood vessel growth in tumors. The goal is to see if this combination can be more effective and safer for patients whose cancer has returned or worsened after their first treatment.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of ACC that has not responded to standard treatments like mitotane or chemotherapy. They should also have measurable cancer that can be tracked during the study. Participants will receive close monitoring and can expect to contribute to important research that may lead to new treatment options for others with this challenging disease. If you or someone you know is considering this trial, it's essential to review the eligibility criteria and discuss it with a healthcare provider.

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ALL

Eligibility 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≤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)
• • 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:
• • 1. 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;
• • 2. Have central nervous system metastasis with symptoms and need hormonal intervention;
• • 3. Had received strong CYP3A4 inhibitors within one week prior to enrollment or received 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 to starting the study drug;
• • 12. Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug;
• • 13. An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the 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.