NCT06831175

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

• Adrenal Cortical Carcinoma
• Adrenal Cortical Cancer
• Adrenal Cancer

Interventions

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

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-12-31
• Completion: 2031-12-31
• First posted: 2025-02-17
• Last updated: 2025-06-03

Locations

1 site across 1 country: China