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

Brief Title

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

Official Title

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

Brief Summary

      Adrenocortical carcinoma (ACC) is a rare aggressive malignant tumor. According to the
      literature, the 5-year survival rate of ACC is 12%-47%. For patients with advanced ACC,
      mitotane alone or combined with traditional chemotherapy was the first-line standard
      treatment, but its progression-free survival was only about 1 year. However, for patients who
      fail the first-line treatment, there is a lack of effective treatment. For ACC patients who
      had failed first-line chemotherapy, a phase II clinical trial found that the objective
      response rate and the disease control rate of PD-1 inhibitor Keytruda were 14% and 64%
      respectively, and no grade 3 or 4 adverse events were observed. Anti-tumor angiogenic drugs
      combined with PD-1 inhibitors have shown impressive clinical data in many solid tumors. This
      study is aimed to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined
      with apatinib in patients with recurrent or metastatic ACC after standard treatment failure,
      and to seek new treatment for this population.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

objective response rate

Condition

Adrenocortical Carcinoma

Intervention

Camrelizumab

Study Arms / Comparison Groups

 Arm 1

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

43

Start Date

April 1, 2020

Completion Date

April 1, 2025

Primary Completion Date

April 1, 2023

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +86 18980606753, [email protected]

NCT ID

NCT04318730

Organization ID

ChiCTR1900028111

Responsible Party

Principal Investigator

Study Sponsor

West China Hospital

Study Sponsor

, , 

Verification Date

March 2020