Safety and Efficacy of Amlotinib in the Treatment of Recurrent Craniopharyngioma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Aims: 1. To assess progression-free survival (PFS) and overall survival (OS) of patients with recurrent craniopharyngiomas treated with amrlotinib. 2. To analyze the disease control rate (DCR) of the Anrotinib treatment regimen in patients with recurrent craniopharyngiomas, including the proportion of patients in complete remission, partial remission and stable disease. 3. Monitor and evaluate the safety of amrutinib, especially the occurrence of drug-related adverse events (AEs) .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75 years old, regardless of gender

• recurrent craniopharyngioma (recurrence after total resection or regrowth of residual tumor) confirmed by pathology and imaging data

• predominantly cystic or solid recurrence of the tumor

• measurable lesions (according to the RECIST criteria)

• Karnofsky score ≥ 70, expected survival ≥ 3 months

• laboratory parameters (liver and kidney function, blood tests, etc.) within the normal range or under control

• signed informed consent and willing to participate in the study

Locations
Other Locations
China
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
RECRUITING
Guangzhou
Contact Information
Primary
Jun Pan, MD, Ph.D
1448875873@qq.com
+86-13076878155
Backup
Yilamujiang Ainiwan, MD, Ph.D
1531506809@qq.com
+86-18620263425
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2028-04-20
Participants
Target number of participants: 57
Treatments
Experimental: A single-center, open-label, single-arm, experimental clinical trial without any control group
This is a single-center, open-label, single-arm, experimental clinical trial without any control group. The study was conducted in patients with recurrent craniopharyngiomas
Related Therapeutic Areas
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov