NCT06970145 Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma
| NCT ID | NCT06970145 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Craniopharyngiomas |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2026-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 57 participants in total. It began in 2025-04-25 with a primary completion date of 2026-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06970145 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Craniopharyngiomas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06970145 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06970145 currently recruiting?
Yes, NCT06970145 is actively recruiting participants. Contact the research team at 1448875873@qq.com for enrollment information.
Where is the NCT06970145 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06970145 clinical trial?
NCT06970145 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 57 participants.