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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 (Jun 2026). This Phase 2 trial studies multiple treatments including Camrelizumab and Apatinib for adrenal cortical carcinoma.

Phase 2RecruitingWest China HospitalNCT06831175Data as of Jun 2026Location: China

Treatment: Camrelizumab · Apatinib · mitotaneAdrenocortical 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Camrelizumab

Targeted therapy

Apatinib

Other

mitotane

Cancer type

Tumor Agnostic

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Frequently asked questions

Is NCT06831175 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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