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RecruitingPhase 1Phase 2NCT06970145

Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

57 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Craniopharyngiomas

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

  • Age 18-75 years old, regardless of gender
  • recurrent craniopharyngioma (recurrence after total resection or regrowth of residual 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 the normal range or under control
  • signed informed consent and willing to participate in the study

Exclusion Criteria9

  • 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-up visits or understand the purpose of the study

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Interventions

DRUGAnlotinib

Anlotinib Hydrochloride Capsules (12mg),Chiatai Tianqing Pharma (China).

Locations(1)

Southern Medical University, Nanfang Hospital, Department of Neurosurgery

Guangzhou, Guangdong, China

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NCT06970145