Using Amlotinib to treat recurrent craniopharyngiomas
Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma
This study is testing if the drug amlotinib can help people with recurring craniopharyngiomas feel better and live longer while keeping an eye on any side effects.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 57 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Drugs / interventions | anlotinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06970145 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with recurrent craniopharyngiomas confirmed by pathology and imaging.
Not a fit: Patients with primary craniopharyngiomas or those with severe uncontrolled health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent craniopharyngiomas.
How similar studies have performed: While this approach is novel for craniopharyngiomas, similar targeted therapies have shown promise in other tumor types.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.