A Phase 1/2 interventional study of Anlotinib in Craniopharyngiomas, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 1/2, Interventional, and Treatment
Primary Aim:
To assess the objective remission rate (ORR) of patients with recurrent craniopharyngiomas treated with anlotinib .
Secondary Aims:
This study is a single-center, open-label, single-arm clinical trial designed to evaluate the safety and efficacy of anlotinib in the treatment of recurrent craniopharyngioma. Primary endpoints include progression-free survival (PFS), overall survival (OS), and objective remission rate (ORR), with assessment of treatment-related adverse events and quality of life.
Analysis Set:
Full Analysis Set (FAS): includes all patients who are randomized into the study, have received at least received at least one dose of study drug and have measurable baseline tumors.FAS will be used for efficacy FAS will be used for efficacy analysis. Per-Protocol Set (PPS): In the FAS, patients with at least one post-dose tumor imaging evaluation and a compliant tumor.
PPS: In the FAS, patients with at least one post-dose tumor imaging assessment, good compliance, and no significant violations or deviations from the trial protocol.
PPS will be used for secondary efficacy analysis. Safety Set (SS): Includes all patients who have received at least one dose of drug therapy and have completed at least one safety assessment.
SS will be used for safety analysis.
Sample size determination:
This is an experimental clinical study with the primary objective of assessing the safety and preliminary efficacy of the drug.
The sample size was designed to be relatively small due to resource constraints and the nature of experimental clinical studies. Based on the literature references and study design, we expected to enroll approximately 57 subjects.
Statistical analysis All statistical analyses will be performed using SAS 9.2 statistical analysis software. Separate independent efficacy and safety analyses will be performed, and no control will be established.
efficacy and safety analyses will be performed separately, with no control group and no between-group comparisons.ORR and DCR will be described using frequency and percentage, PFS and OS will be described using frequency and percentage.
ORR and DCR were described using frequency and percentage, PFS and OS were estimated by Kaplan-Meier method for survival, and All treatment-related adverse events were recorded and analyzed according to CTCAE 5.0 criteria.
65 studies on the registry are indexed under Craniopharyngioma; 21 are open to participants now.
This study's planned enrollment of 57 is above the median of 41 across 45 interventional studies indexed under Craniopharyngioma.
Browse Craniopharyngioma studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a single-center, open-label, single-arm, experimental clinical trial without any control group. The study was conducted in patients with recurrent craniopharyngiomas
Drug: Anlotinib
Anlotinib Hydrochloride Capsules (12mg),Chiatai Tianqing Pharma (China).
Also known as: Anlotinib Hydrochloride Capsules
Measurement of tumor volume on imaging (MRI)
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)
Time frame: Through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nanfang Hospital, Southern Medical University