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New treatment option for Adrenal Cortical Carcinoma
Official title Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma
ClinicalTrials.gov ID: NCT06831175
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 adrenal cortical carcinoma.
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 to 70
You may be able to join if
- Histopathological diagnosis of adrenocortical carcinoma;
- Patients with unresectable advanced adrenocortical carcinoma who have not received first-line standard treatment;
- Age ≥18 years old, ≤70 years old;
- No gender limit;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
You likely can't join if
- A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, carcinoma in situ of...
- Known allergic reactions to other monoclonal antibodies, active ingredient of mitotane, active ingredient of apatinib and or any excipients;
- CNS metastases with clinical symptoms such as brain edema, requiring hormonal intervention, or progression of brain metastases;
- Patients who received potent CYP3A4 inhibitor treatment within one week before enrollment or a potent CYP3A4 inducer treatment within two weeks...
- Patients with hypertension not well controlled by antihypertensive drug therapy alone (systolic blood pressure \> 140 mmHg, diastolic blood pressure...
- NYHA class III-IV congestive heart failure;
See the full eligibility criteria
- Histopathological diagnosis of adrenocortical carcinoma;
- Patients with unresectable advanced adrenocortical carcinoma who have not received first-line standard treatment;
- Age ≥18 years old, ≤70 years old;
- No gender limit;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1);
- Major organ function within 28 days before treatment, meeting the following criteria: \- Blood routine test criteria (without blood transfusion within 14 days) : Hemoglobin (HB) ≥80g/L Absolute neutrophil count (ANC)...
- Women of childbearing age should agree that they must use a contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study and for 120 days after the study; Patients had a negative...
- Study participants provided written informed consent and were willing and able to follow planned visits, study treatments, laboratory tests, and other experimental procedures.
- A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary carcinoma;
- Known allergic reactions to other monoclonal antibodies, active ingredient of mitotane, active ingredient of apatinib and or any excipients;
- CNS metastases with clinical symptoms such as brain edema, requiring hormonal intervention, or progression of brain metastases;
- Patients who received potent CYP3A4 inhibitor treatment within one week before enrollment or a potent CYP3A4 inducer treatment within two weeks before the first use of study drug;
- Patients with hypertension not well controlled by antihypertensive drug therapy alone (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg);
- NYHA class III-IV congestive heart failure;
- Occurrence of arterial/venous thrombosis events within 1 year before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), myocardial infarction...
- QT interval \> 500 ms;
- Prior systemic immunosuppressive therapy;
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies;
- TKI treatment within 2 weeks before the first dose;
- Participating in other treatment drug clinical trials within 4 weeks before the first dose;
- Received an antineoplastic vaccine or a live vaccine within 4 weeks before the first dose of study drug;
- Major surgery or major trauma within 4 weeks before the first dose of study medication;
- Had a serious infection (CTCAE \> 2) within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; The presence of active pulmonary...
- Have an active autoimmune disease, a history of autoimmune disease (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to...
- Have a history of immunodeficiency, including being HIV positive or having other acquired or congenital immunodeficiency disorders, or having a history of organ or bone marrow transplantation;
- A history of non-infectious pneumonia;
- Active pulmonary tuberculosis infection detected by medical history or CT examination, or a history of active pulmonary tuberculosis infection within 1 year before enrollment or patients who had a history of active...
- people with active hepatitis (HBV DNA≥2000 IU/ml or 10000 copies/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay);
- A known history of psychotropic drug abuse, alcohol abuse, and drug use;
- Have GI bleeding symptoms and risk of bleeding;
- Are pregnant or lactating;
- Have medical history, disease, treatment, or laboratory abnormalities that may interfere with the results of the trial or prevent the subject from participating fully in the study, or the investigator believes that...
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 to 70 years. 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.