CraniopharyngiomasPhase 1/2NCT06970145
Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma
A Phase 1/2 study testing Anlotinib in people with Craniopharyngiomas, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Craniopharyngiomas
- What is being tested?
- Anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 20 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Southern Medical University, Nanfang Hospital, Department of Neurosurgery
Guangzhou, Guangdong, 510515
Jun Pan, MD, Ph.D, +86-13076878155, 1448875873@qq.com
Jun Pan, MD, Ph.D
About this study
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) .
Read the detailed 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.
- Conditions
- Craniopharyngiomas
- Being tested
- Anlotinib
- Keywords
- Anlotinib, Craniopharyngiomas, Targeted therapy
- Medical subject headings
- Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnlotinibDrug
Also called Anlotinib Hydrochloride Capsules
Anlotinib Hydrochloride Capsules (12mg),Chiatai Tianqing Pharma (China).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start25 Apr 2025
- Primary completion20 Apr 2026 (estimated)
- Study completion20 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniopharyngiomasStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970145
- Sponsor's protocol ID
- NFEC-2025-156
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Anlotinib in the Treatment of Recurrent Craniopharyngioma
- ClinicalTrials.gov ID
- NCT06970145
- Acronym / sponsor ID
- NFEC-2025-156
- Conditions
- Craniopharyngiomas
- Keywords
- Anlotinib, Craniopharyngiomas, Targeted therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 20 Apr 2028 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single-center, open-label, single-arm, experimental clinical trial without any control group | Experimental | Drug: AnlotinibThis is a single-center, open-label, single-arm, experimental clinical trial without any control group. The study was conducted in patients with recurrent craniopharyngiomas |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnlotinibAlso: Anlotinib Hydrochloride CapsulesAnlotinib Hydrochloride Capsules (12mg),Chiatai Tianqing Pharma (China). | Drug | A single-center, open-label, single-arm, experimental clinical trial without any control group |
Primary outcome
Measurement of tumor volume on imaging (MRI)
Time frame: Through study completion, an average of 1 year
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anlotinib in people with Craniopharyngiomas, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pan, MD, Ph.D (+86-13076878155, 1448875873@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of tumor volume on imaging (MRI) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.