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New treatment option for Adrenocortical Carcinoma
Official title Phase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma
ClinicalTrials.gov ID: NCT04318730
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adrenocortical carcinoma.
Also referred to as Apatinib.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Adrenocortical carcinoma (ACC) is a rare aggressive malignant tumor. According to the literature, the 5-year survival rate of ACC is 12%-47%.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed diagnosis of adrenocortical carcinoma;
- Patients with metastatic or inoperable adrenocortical carcinoma that has progressed, metastasized, or recurred after first-line standard treatment...
- Aged \>=18 years;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- At least one measurable lesion, according to RECIST 1.1;
You likely can't join if
- Patients with another primary malignancy within 5 years prior to starting the study drug, except for cured in situ cervical carcinoma and cured...
- 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;
See the full eligibility criteria
- 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...
- 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...
- Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment;
- Have signed consent form.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.