Recurrent craniopharyngiomas
Conditions
Interventions
Interventional group:Oral Anrotinib Capsule Therapy
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor volume reduction to less than 20% of pre-drug volume on imaging (MRI) at at least 1 year of post-drug follow-up;Objective response rate;Incidence and severity of treatment-related adverse events;Treatment discontinuation rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Overall survival;Treatment-related Adverse events;Incidence of adverse events in specific organ systems;LLaboratory tests Abnormal marker assessment;Quality of life change assessment; | — |
Countries
China
Contacts
Public ContactJun Pan
Nanfang Hospital, Southern Medical University
Outcome results
None listed