Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma

NCT06970145 | Recruiting Phase 1

• 1 other identifier: NFEC-2025-156
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Aim: To assess the objective remission rate (ORR) of patients with recurrent craniopharyngiomas treated with anlotinib . Secondary Aims:

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

Conditions

Craniopharyngiomas

Keywords

Anlotinib; Craniopharyngiomas; Targeted therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  Through study completion, an average of 1 year

Study Arms (1)

A single-center, open-label, single-arm, experimental clinical trial without any control group

EXPERIMENTAL

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

Interventions

Anlotinib DRUG

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

Also known as: Anlotinib Hydrochloride Capsules

A single-center, open-label, single-arm, experimental clinical trial without any control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Southern Medical University, Nanfang Hospital, Department of Neurosurgery

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Craniopharyngioma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Jun Pan, MD, Ph.D

CONTACT

+86-13076878155; 1448875873@qq.com

Yilamujiang Ainiwan, MD, Ph.D

CONTACT

+86-18620263425; 1531506809@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 14, 2025
• Study Start: April 25, 2025
• Primary Completion: April 20, 2026
• Study Completion (Estimated): April 20, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)