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

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ClinicalTrials.gov Identifier: NCT04318730
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Xingchen Peng, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Adrenocortical Carcinoma Drug: Camrelizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 Drug: Camrelizumab
Camrelizumab was administered 200mg iv every 3 weeks, Apatinib was administered 250 mg p.o. qd.
Other Name: Apatinib




Primary Outcome Measures :
  1. objective response rate [ Time Frame: up to 60 months ]
    The rate of complete response and partial response.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318730


Contacts
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Contact: Xingchen Peng +86 18980606753 pxx2014@scu.edu.cn

Sponsors and Collaborators
West China Hospital
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Responsible Party: Xingchen Peng, PhD, Associate Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT04318730    
Other Study ID Numbers: ChiCTR1900028111
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action