Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWest China Hospital
About this trial
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. The efficacy of mitotane monotherapy is approximately 10% to 30%. FIRM-ACT trial reported an objective response rate (ORR) of 23.2% for etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) chemotherapy regimen. Our phase II study found that PD-1 inhibitor camrelizumab and apatinib showed impressive clinical data in the second-line treatment of relapsed and metastatic ACC patients. The aim of this study is to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined with apatinib and mitotane in advanced ACC, and to explore a new treatment strategy for patients with advanced ACC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Camrelizumab
DrugCamrelizumab was administered 200mg IV every 3 weeks.
Apatinib
DrugApatinib was administered 250 mg PO QD.
mitotane
DrugMitotane is administered orally and plasma concentration was measured. The target steady-state plasma concentration is 14-20 mg/L.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: Camrelizumab in combination with apatinib and mitotaneExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
objective response rate
The rate of complete response and partial response.
Time frame
up to 24 monthsSecondary outcomes
1
disease-free survival
The time from the administration of the first dose to first disease progression or death.
Time frame
up to 60 months2
progression-free survival
The time from the commencement of therapy to the first evidence of disease progression or death.
Time frame
up to 60 months3
incidence of adverse events
Graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame
up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov