Phase 2 Study of PD-1 Inhibitor Camrelizumab Combined With Apatinib and Mitotane for Advanced Adrenal Cortical Carcinoma

What this Trial Is About

Adrenal cortical carcinoma ACC is a rare and aggressive cancer with a low 5-year survival rate ranging from 12% to 47%. For advanced ACC, first-line treatment typically involves mitotane alone or combined with chemotherapy, but its effectiveness is limited with progression-free survival around one year and response rates between 10% and 30%. This study aims to evaluate the safety and effectiveness of combining the PD-1 inhibitor camrelizumab with apatinib and mitotane to explore a new treatment option for advanced ACC patients. In this phase II trial, participants will receive camrelizumab at 200 mg intravenously every three weeks, apatinib at 250 mg taken orally once daily, and oral mitotane with plasma levels monitored to maintain a target concentration between 14 and 20 mgL. The study treatment is designed to assess the combined impact of these three drugs on advanced ACC, without comparison to placebo or other groups. Participants will be monitored for up to 24 months to measure the objective response rate, while secondary outcomes include disease-free survival, progression-free survival, and the incidence of adverse events over 60 months. The study involves regular visits for treatment delivery, laboratory tests, and assessments of tumor response. Safety and treatment effects will be closely tracked throughout the study period, with total participation lasting several years depending on individual outcomes.

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