Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma
Recruiting now · Phase 1/Phase 2
Conditions studied: Craniopharyngiomas
In brief
Primary Aim: To assess the objective remission rate (ORR) of patients with recurrent craniopharyngiomas treated with anlotinib . Secondary Aims: 1. To assess progression-free survival (PFS) and overall survival (OS) of patients with recurrent craniopharyngiomas treated with anlotinib. 2. To analyze the disease control rate (DCR) of the anlotinib 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 anlotinib, especially the occurrence of drug-related adverse events (AEs) .
Key facts
- Study ID
- NCT06970145
- Run by
- Nanfang Hospital, Southern Medical University
- People needed
- 57
- Starts
- 2025-04-25
- Expected to finish
- 2028-04-20
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Have a combination of other intracranial tumors or severe brain lesions
- primary craniopharyngioma
- have severe uncontrolled heart, lung, kidney, or liver disease
- children, pregnant or breastfeeding women
- prior treatment with the same investigational drug
- active infections, including HIV, HBV, or HCV infections
- patients who do not meet the contraindications to the medication
- have a history of severe allergy to the investigational drug
- have psychiatric illnesses or cognitive impairments and unable to complete follow-up visits or understand the purpose of the study
Where it is running
- Southern Medical University, Nanfang Hospital, Department of Neurosurgery — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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