At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed adrenocortical carcinoma
- ✓Metastatic or inoperable disease that progressed, metastasized, or recurred after first-line standard treatment
- ✓Age ≥18 years
- ✓At least one measurable lesion per RECIST 1.1
- ✕Another primary malignancy within 5 years (except cured in situ cervical carcinoma or non-melanoma skin cancer)
- ✕Symptomatic CNS metastasis requiring hormonal intervention
- ✕Strong CYP3A4 inhibitors within 1 week or strong CYP3A4 inducers within 2 weeks prior to enrollment
- ✕Poor blood pressure control (SBP >140 mmHg or DBP >90 mmHg)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04318730Phase 2RecruitingUpdate OverdueUpdated 23mo ago · Completion was 31mo agoPhase II Study for Combination of Camrelizumab and Apatinib in the Second-line Treatment of Recurrent or Metastatic Adrenocortical Carcinoma
In Brief
A Phase 2 clinical trial evaluating Camrelizumab for Adrenocortical Carcinoma. Currently recruiting, targeting 21 participants across 1 site.
Signals
Detailed 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. However, for patients who fail the first-line treatment, there is a lack of effective treatment. For ACC patients who had failed first-line chemotherapy, a phase II clinical trial found that the objective response rate and the disease control rate of PD-1 inhibitor Keytruda were 14% and 64% respectively, and no grade 3 or 4 adverse events were observed. Anti-tumor angiogenic drugs combined with PD-1 inhibitors have shown impressive clinical data in many solid tumors. This study is aimed to evaluate the efficacy and safety of PD-1 inhibitor camrelizumab combined with apatinib in patients with recurrent or metastatic ACC after standard treatment failure, and to seek new treatment for this population.
Study Details
Timeline
Interventions
Camrelizumab was administered 200mg iv every 3 weeks, Apatinib was administered 250 mg p.o. qd.