Status:
RECRUITING
Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma
Lead Sponsor:
West China Hospital
Conditions:
Adrenocortical Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of adrenocortical carcinoma;
- 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);
- Aged \>=18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- At least one measurable lesion, according to RECIST 1.1;
- 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)
- Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment;
- Have signed consent form.
Exclusion
- 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;
- Have central nervous system metastasis with symptoms and need hormonal intervention;
- Had received strong CYP3A4 inhibitors within one week prior to enrollment or received strong CYP3A4 inducers within two weeks prior to enrollment;
- Poor control of high blood pressure (SBP\>140mmHg or DBP\>90mmHg);
- Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
- Thromboembolic events occurred within 1 year prior to enrollment;
- ECG QT interval \>500ms;
- Previous systemic immunosuppressive therapy;
- Previous anti-PD-1, anti-PD-L1 antibody or anti- CTLA-4 antibody treatment;
- Received TKI treatment within 2 weeks prior to starting the study drug;
- Participate in clinical trials of other interventional drugs within 4 weeks prior to starting the study drug;
- Received systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to starting the study drug;
- An anti-tumor vaccine or a live vaccine was given within 4 weeks prior to starting the study drug;
- Major surgery or severe trauma within 4 weeks prior to starting the study drug;
- Severe infections occurred within 4 weeks prior to starting the study drug;
- Have an active autoimmune disease or a history of autoimmune diseases;
- Have a history of immunodeficiency;
- Have an active tuberculosis infection;
- Have active hepatitis;
- Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
- Active infection, or patients are pregnant or breast-feeding.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04318730
Start Date
October 1 2020
End Date
April 1 2025
Last Update
July 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041