Belzutifan as a preoperative option for pheochromocytoma/paraganglioma
Official title: Safety and Efficacy of Belzutifan in Preoperative Preparation for Patients With Pheochromocytoma/Paraganglioma (PPGL): A Pilot Study
Run by Xiangya Hospital of Central South University · NCT07907341 · Data updated 2026-11-12
This study tests whether belzutifan can safely help prepare patients with pheochromocytoma or paraganglioma for surgery and reduce catecholamine-related effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 14 Years to 85 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT07907341 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are aged 14–85 with imaging/biochemical confirmation of adrenal pheochromocytoma or retroperitoneal paraganglioma, scheduled for surgery, ASA I–III, and adequate blood counts and organ function per protocol.
✕Probably not a fit
Patients with significant organ dysfunction, inability to consent, or noncompliance with study procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 interventional trial investigates the safety and potential perioperative benefits of belzutifan in patients with PPGL undergoing surgery. Participants receive belzutifan before their operation, with assessments focused on catecholamine production, safety, and perioperative outcomes. Eligible patients are adults or adolescents (14–85) with imaging/biochemical confirmation of adrenal pheochromocytoma or retroperitoneal paraganglioma and suitable anesthesia risk, who can provide informed consent. The study is conducted at Xiangya Hospital in Changsha, China, led by Dr. Longfei Liu. Results will inform whether belzutifan can be used as a perioperative preparation drug for PPGL.
Why it matters
Potential benefit: If successful, belzutifan could help stabilize catecholamine activity and improve surgical safety for PPGL patients.
How similar studies have gone: Previous data suggest biological activity of belzutifan in related contexts, but this perioperative use in PPGL is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 14 to 85 years. 2. Adrenal pheochromocytoma or retroperitoneal paraganglioma suspected based on imaging and biochemical diagnoses. 3. Scheduled for surgical treatment. 4. American Society of Anesthesiologists (ASA) physical status classification of Grade Ⅰ to Ⅲ. 5. Informed consent obtained from the patient or their legal guardian. 6. Confirmed non-pregnant and non-lactating status. 7. Laboratory requirements: * Absolute Granulocyte Count (AGC) \> 1.5 × 10⁹/L; * Platelet count \> 80 × 10⁹/L; * Hemoglobin (Hb) \> 90 g/L; * Serum bilirubin \< 1.5 × the upper limit of normal (ULN); * Serum creatinine \< 1.5 × ULN or creatinine clearance \>= 60 mL/min; * Negative serum human chorionic gonadotropin (hCG) test result. 8. Capacity to understand the study and willingness to sign a written informed consent form. Exclusion Criteria: 1. Incapable of correctly understanding the content of questionnaires and unable to cooperate with researchers. 2. Receiving other anti-tumor drug therapies. 3. Pregnant or lactating women, and men or women of childbearing age who refuse to take appropriate contraceptive measures. 4. A history of allergic reactions to belzutifan or hypoxia-inducible factor (HIF) inhibitors. 5. Presence of multiple factors affecting oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.) or other conditions interfering with medication intake. 6. Severe myelosuppression or coagulation abnormalities (International Normalized Ratio (INR) \> 1.5, or Prothrombin Time (PT) \> upper limit of normal (ULN) by 4 seconds, or Activated Partial Thromboplastin Time (APTT) \> 1.5 × ULN), a bleeding tendency, or ongoing thrombolytic or anticoagulant therapy. 7. A history of treatment with other HIF inhibitors. 8. Prior receipt of chemotherapy, targeted therapy, biological agents, or other investigational treatments within the 4 weeks prior to the first administration of the study intervention. 9. Active or uncontrolled comorbid diseases, including but not limited to: * Uncontrolled myocardial ischemia or myocardial infarction, cardiac arrhythmias (including corrected QT interval (QTc) \>= 480 ms), and uncontrolled congestive heart failure of New York Heart Association (NYHA) Grade \>= 2; * Clinically significant heart disease, including unstable angina pectoris, acute myocardial infarction, or a history of Coronary Artery Bypass Grafting (CABG) or Percutaneous Transluminal Coronary Angioplasty (PTCA) within 6 months prior to study enrollment, or congestive heart failure of NYHA Grade Ⅲ or Ⅳ; * Persistent or active infection; * Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral therapy; * Renal failure requiring hemodialysis or peritoneal dialysis; * A history of immunodeficiency, including Human Immunodeficiency Virus (HIV) infection or other acquired/congenital immunodeficiency diseases, or a history of organ transplantation. 10. A history of seizures requiring medical treatment. 11. Occurrence of any of the following conditions within 6 months prior to study registration: Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA); severe or unstable cardiac arrhythmia; pulmonary embolism or untreated Deep Venous Thrombosis (DVT). 12. A history of psychoactive substance abuse with inability to abstain, or presence of mental disorders. 13. Concomitant use of drugs that interact with belzutifan. 14. Patients with stable disease who decline surgical treatment. 15. Resting pulse oximetry reading \< 92%, or requirement for intermittent oxygen supplementation, or long-term oxygen therapy.
Where it's running
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Xiangya Hospital of Central South University
Changsha, Hunan, China Recruiting
Study contacts
- Principal investigator: Longfei Liu, Doctor of Medicine — Xiangya Hospital of Central South University
- Study coordinator: Chao Wang, Master
- Email: wangchao296@csu.edu.cn
- Phone: +86 151 1103 1075
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.