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

NCT06831175 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-06-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2026-12-31
Completion
2031-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06831175 on ClinicalTrials.gov