Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma
Study Details
Study Description
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 |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- objective response rate [up to 60 months]
The rate of complete response and partial response.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed diagnosis of adrenocortical carcinoma;
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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);
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Aged >=18 years;
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Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
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At least one measurable lesion, according to RECIST 1.1;
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Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion): HB≥80g/L, ANC≥1.5x109/L, PLT ≥80x109/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)
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Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment;
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Have signed consent form.
Exclusion Criteria:
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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;
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Have central nervous system metastasis with symptoms and need hormonal intervention;
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Had received strong CYP3A4 inhibitors within one week prior to enrollment or received strong CYP3A4 inducers within two weeks prior to enrollment;
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Poor control of high blood pressure (SBP>140mmHg or DBP>90mmHg);
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Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
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Thromboembolic events occurred within 1 year prior to enrollment;
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ECG QT interval >500ms;
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Previous systemic immunosuppressive therapy;
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Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment;
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Received TKI treatment within 2 weeks prior to starting the study drug;
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Participate in clinical trials of other interventional drugs within 4 weeks prior to starting the study drug;
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Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug;
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An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the study drug;
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Major surgery or severe trauma within 4 weeks prior to starting the study drug;
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Severe infections occurred within 4 weeks prior to starting the study drug;
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Have an active autoimmune disease or a history of autoimmune diseases;
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Have a history of immunodeficiency;
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Have an active tuberculosis infection;
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Have active hepatitis;
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Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
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Active infection, or patients are pregnant or breast-feeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- West China Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChiCTR1900028111