OncoMatch/Clinical Trials/NCT06831175
Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma
Is NCT06831175 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Camrelizumab and Apatinib for adrenal cortical carcinoma.
Treatment: Camrelizumab · Apatinib · mitotane — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
Cannot have received: immunosuppressive therapy
Prior systemic immunosuppressive therapy
Cannot have received: tyrosine kinase inhibitor
TKI treatment within 2 weeks before the first dose
Lab requirements
Blood counts
Hemoglobin (HB) ≥80g/L; ANC ≥1.5×10^9/L; Platelet (PLT) ≥80×10^9/L
Kidney function
Serum creatinine ≤1.5x ULN or creatinine clearance (CCr)≥60 ml/min
Liver function
Total bilirubin (TBIL) ≤1.5x ULN; ALT and AST ≤2.5x ULN or ≤5x ULN if liver metastases are present
Cardiac function
Cardiac markers and natriuretic peptide (BNP) ≤ULN; QT interval > 500 ms excluded; NYHA class III-IV congestive heart failure excluded
Major organ function within 28 days before treatment, meeting the following criteria: ... see full criteria above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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