Actively Recruiting
Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma
Led by West China Hospital · Updated on 2025-06-03
28
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of adrenocortical carcinoma
- Unresectable advanced adrenocortical carcinoma without prior first-line standard treatment
- Age between 18 and 70 years
- No gender restriction
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- At least one measurable tumor lesion by RECIST v1.1 criteria
- Adequate blood counts and organ function within 28 days before treatment
- Women of childbearing potential agree to use contraception during study and 120 days after
- Negative pregnancy test within 7 days before study entry and non-lactating
- Men agree to use contraception during study and 6 months after end of study
- Provide informed consent and agree to follow study visits and procedures
You will not qualify if you...
- History of other malignancies within past 5 years except certain skin and cervical cancers
- Known allergies to monoclonal antibodies, mitotane, apatinib, or their components
- Symptomatic brain metastases requiring treatment or progression of brain metastases
- Recent use of potent CYP3A4 inhibitors or inducers before study drug
- Poorly controlled hypertension (BP >140/90 mmHg)
- New York Heart Association class III-IV heart failure
- Thrombosis events within 1 year prior to enrollment
- QT interval over 500 ms
- Prior systemic immunosuppressive therapy
- Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
- Tyrosine kinase inhibitor treatment within 2 weeks before first dose
- Participation in other drug trials within 4 weeks before first dose
- Recent vaccinations, major surgery, or major trauma within 4 weeks before first dose
- Serious infections or active pulmonary inflammation within 4 weeks before first dose
- Active autoimmune diseases or history excluding stable thyroid conditions and certain childhood allergies
- History of immunodeficiency or organ/bone marrow transplantation
- History of non-infectious pneumonia
- Active or recent pulmonary tuberculosis infection
- Active hepatitis B or C infection
- History of substance abuse
- Gastrointestinal bleeding or bleeding risk
- Pregnant or lactating
- Any medical or laboratory conditions that may interfere with trial participation or safety as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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