Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma

Phase

1/2

Condition

Brain Tumor

Pituitary Disorders

Brain Cancer

Treatment

Anlotinib

Clinical Study ID

NCT06970145

NFEC-2025-156

Ages 18-75
All Genders

Study Summary

Primary Aim:

To assess the objective remission rate (ORR) of patients with recurrent craniopharyngiomas treated with anlotinib .

Secondary Aims:

To assess progression-free survival (PFS) and overall survival (OS) of patients with recurrent craniopharyngiomas treated with anlotinib.
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.
Monitor and evaluate the safety of anlotinib, especially the occurrence of drug-related adverse events (AEs) .

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18-75 years old, regardless of gender
recurrent craniopharyngioma (recurrence after total resection or regrowth ofresidual tumor) confirmed by pathology and imaging data
predominantly cystic or solid recurrence of the tumor
measurable lesions (according to the RECIST criteria)
Karnofsky score ≥ 70, expected survival ≥ 3 months
laboratory parameters (liver and kidney function, blood tests, etc.) within thenormal range or under control
signed informed consent and willing to participate in the study

Exclusion

Exclusion Criteria:

Have a combination of other intracranial tumors or severe brain lesions
primary craniopharyngioma
have severe uncontrolled heart, lung, kidney, or liver disease
children, pregnant or breastfeeding women
prior treatment with the same investigational drug
active infections, including HIV, HBV, or HCV infections
patients who do not meet the contraindications to the medication
have a history of severe allergy to the investigational drug
have psychiatric illnesses or cognitive impairments and unable to complete follow-upvisits or understand the purpose of the study

Study Design

Anlotinib

1/2

April 25, 2025

April 20, 2028

Study Description

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.

Connect with a study center

Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou, Guangdong 510515
China
Site Not Available
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou 1809858, Guangdong 1809935 510515
China
Active - Recruiting

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