Using Amlotinib to treat recurrent craniopharyngiomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of amlotinib in patients with recurrent craniopharyngiomas. It is a single-center, open-label, single-arm study that aims to assess the objective remission rate, progression-free survival, and overall survival of participants. The study also monitors treatment-related adverse events and quality of life. Patients will be closely monitored for their response to the treatment and any side effects experienced during the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• Southern Medical University, Nanfang Hospital, Department of Neurosurgery
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jun Pan, MD, Ph.D
• Email: 1448875873@qq.com
• Phone: +86-13076878155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.