Phase II Study of PD-1 Inhibitor Combined With Apatinib and Mitotane in the Treatment of Advanced Adrenal Cortical Carcinoma

Sponsor
West China Hospital
Study ID
NCT06831175
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adrenal Cancer
  • Adrenal Cortical Cancer
  • Adrenal Cortical Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab was administered 200mg IV every 3 weeks.
  • Apatinib — DRUG
    Apatinib was administered 250 mg PO QD.
  • mitotane — DRUG
    Mitotane is administered orally and plasma concentration was measured. The target steady-state plasma concentration is 14-20 mg/L.

Study Details

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.

Key Dates

Start date
Mar 15, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2031

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab in combination with apatinib and mitotane

Primary Outcome Measure

objective response rate [ Time Frame: up to 24 months ]

Central Contacts

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