Sorafenib for Recurrent or Progressive Adamantinomatous Craniopharyngioma,a Phase II Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400094147

Enrollment

Unknown

Registered

2024-12-17

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adamantinomatous Craniopharyngioma

Interventions

Sorafenib treatment group(Adult):Sorafenib 400mg po qd.

Sorafenib treatment group(Child):Sorafenib 200mg-250mg/m2 po qd.

Eligibility

Sex/Gender

All

Age

No minimum to 100 Years

Inclusion criteria

Inclusion criteria: 1. After surgical resection, the pathological diagnosis was confirmed as amelogenic craniopharyngioma; 2. The course of the disease is recurrent or progressive; 3. The gene test was performed and CTNNB1 mutation was positive; 4. After neurosurgical evaluation, it is difficult to perform surgical resection again; 5. Can accept craniocerebral pituitary MRI scan plus contrast; 6. A measurable lesions; 7. Normal hematopoietic function: neutrophil absolute value =1.5×10^9/L, hemoglobin 80g/L, platelets 75×10^9/L; 8. Normal liver function: total bilirubin = 1.5 times the upper limit of normal, AST or ALT= 1.5 times the upper limit of normal; 9 . Normal renal function: creatinine clear rate =50 mL/min.

Exclusion criteria

Exclusion criteria: 1. Anticoagulant drugs need to be used due to comorbidities: warfarin, heparin, Factor Xa inhibitor(Rivaroxaban, Apixaban, Edoxaban), clopidogrel; 2. CYP3A4 inducers are required for comorbidities: dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital; 3. CYP3A4 suppressant is required due to comorbidities: Boceprevir, Indinavir, Nelfinavir, Lopinavir/ritonavir, Saquinavir, Telaprevir,Ritonavir, Clarithromycin, Conivaptan, Itraconazole, Ketoconazole, Mibefradil, Nefazodone, Posaconazole, Voriconazole, Telithromycin; 4. Pregnancy; 5.Heart failure > Grade II (New York Heart Association (NYHA)); 6. Uncontrollable hypertension: systolic blood pressure =150mmHg, diastolic blood pressure =90 mmHg; 7. History of gastrointestinal bleeding.

Design outcomes

Primary

Measure	Time frame
Objective response rate;	—

Secondary

Measure	Time frame
Time to response;Duration of Response;Progression Free Survival;Quality of Life;Adverse event;	—

Countries

China

Contacts

Public ContactShen Guo-ping

The First Affiliated Hospital of Sun Yat-sen University

shenguop@mail.sysu.edu.cn+86 20 8775 5766

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026