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) .
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age 18-75 years old, regardless of gender
2. recurrent craniopharyngioma (recurrence after total resection or regrowth of residual tumor) confirmed by pathology and imaging data
3. predominantly cystic or solid recurrence of the tumor
4. measurable lesions (according to the RECIST criteria)
5. Karnofsky score ≥ 70, expected survival ≥ 3 months
6. laboratory parameters (liver and kidney function, blood tests, etc.) within the normal range or under control
7. signed informed consent and willing to participate in the study
Exclusion Criteria:
1. Have a combination of other intracranial tumors or severe brain lesions
2. primary craniopharyngioma
3. have severe uncontrolled heart, lung, kidney, or liver disease
4. children, pregnant or breastfeeding women
5. prior treatment with the same investigational drug
6. active infections, including HIV, HBV, or HCV infections
7. patients who do not meet the contraindications to the medication
8. have a history of severe allergy to the investigational drug
9. have psychiatric illnesses or cognitive impairments and unable to complete follow-up visits or understand the purpose of the study
Primary outcome measure(s)
Measurement of tumor volume on imaging (MRI) — Through study completion, an average of 1 year Measurement of tumor volume on imaging (MRI): A\*B\*C/2 (A,B,C are the maximum length, width, and height of the tumor, respectively)
Trial sites (1)
Facility
City
Region
Status
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou
Guangdong
Recruiting
More Nanfang Hospital, Southern Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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