Safety and Efficacy of Amlotinib in the Treatment of Recurrent Craniopharyngioma

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called amlotinib to see how effective and safe it is for patients with recurrent craniopharyngiomas, which are rare brain tumors that can come back after treatment. The main goal is to find out how many patients have a positive response to the treatment, while also looking at how long patients can live without the tumor getting worse and how many patients can achieve either complete or partial remission. The trial will also monitor any side effects that might occur from taking amlotinib.

To participate in this trial, patients need to be between 18 and 75 years old and have a confirmed case of recurrent craniopharyngioma. They should have measurable tumor lesions and a good level of overall health, indicated by a Karnofsky score of 70 or higher, which means they can manage daily activities fairly well. Participants will need to provide informed consent and may expect regular check-ups during the study. The trial is currently recruiting, and it's important to note that certain people, such as those with other significant health issues or severe allergies to the drug, may not be eligible to participate.

Gender

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Eligibility criteria

• 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