Status:
RECRUITING
Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Craniopharyngiomas
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ove...
Detailed Description
This study is a single-center, open-label, single-arm clinical trial designed to evaluate the safety and efficacy of anlotinib in the treatment of recurrent craniopharyngioma. Primary endpoints includ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 20 2028
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06970145
Start Date
April 25 2025
End Date
April 20 2028
Last Update
November 18 2025
Active Locations (1)
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1
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou, Guangdong, China, 510515