Belzutifan to prepare people with pheochromocytoma or paraganglioma for surgery
Tests belzutifan before surgery in people with pheochromocytoma or paraganglioma.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Belzutifan in Preoperative Preparation for Patients With Pheochromocytoma/Paraganglioma (PPGL)
Key facts
- Where
- Changsha, ChinaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 14 to 85 with a suspected adrenal pheochromocytoma or retroperitoneal paraganglioma who are scheduled for surgery. It tests belzutifan as preparation before the operation.
- Age
- 14 to 85 years
- Sex
- All sexes can join.
- Disease stage
- Suspected adrenal pheochromocytoma or retroperitoneal paraganglioma, based on imaging and biochemical tests. Surgery is planned. ASA physical status Grade I to III.
- Earlier treatment
- No other anti-tumor drug treatment now. No earlier treatment with other HIF inhibitors. No chemotherapy, targeted therapy, biological agents or other investigational treatments in the 4 weeks before the first dose.
- Biomarker or test result
- Blood counts, bilirubin and kidney tests must meet limits in the record, for example platelet count > 80 × 10⁹/L and hemoglobin (Hb) > 90 g/L. A negative serum hCG test is required.
Main reasons for not taking part
- Pregnant or breastfeeding
- Allergy to belzutifan or HIF inhibitors
- Severe heart disease or uncontrolled heart rhythm problems
- Kidney failure needing dialysis, HIV infection, or an organ transplant
- Resting pulse oximetry reading < 92% or needing oxygen therapy
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 85 years old?
Source: NCT07907341, who can take part
Where in China
- Xiangya Hospital of Central South UniversityChangsha, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Longfei Liu,MD
- Trial code
- NCT07907341
- Record updated
- 30 October 2026
- Original description
It is preliminarily clarified that belzutifan exerts an inhibitory effect on catecholamine synthesis in pheochromocytoma and paraganglioma (PPGL), and its safety is simultaneously confirmed, thereby providing preliminary experimental results for the further exploration of belzutifan as a perioperative preparation drug for patients with PPGL.Read full original descriptionShow less
Safety and Efficacy of Belzutifan in Preoperative Preparation for Patients With Pheochromocytoma/Paraganglioma (PPGL): A Pilot Study
It is preliminarily clarified that belzutifan exerts an inhibitory effect on catecholamine synthesis in pheochromocytoma and paraganglioma (PPGL), and its safety is simultaneously confirmed, thereby providing preliminary experimental results for the further exploration of belzutifan as a perioperative preparation drug for patients with PPGL.
Inclusion: Aged 14 to 85 years; Adrenal pheochromocytoma or retroperitoneal paraganglioma suspected based on imaging and biochemical diagnoses; Scheduled for surgical treatment; American Society of Anesthesiologists (ASA) physical status classification of Grade Ⅰ to Ⅲ; Informed consent obtained from the patient or their legal guardian; Confirmed non-pregnant and non-lactating status; 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; Capacity to understand the study and willingness to sign a written informed consent form.
Exclusion: Receiving other anti-tumor drug therapies; A history of treatment with other HIF inhibitors; 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; 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); Concomitant use of drugs that interact with belzutifan; Resting pulse oximetry reading < 92%, or requirement for intermittent oxygen supplementation, or long-term oxygen therapy; A history of allergic reactions to belzutifan or hypoxia-inducible factor (HIF) inhibitors; Presence of multiple factors affecting oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction, etc.) or other conditions interfering with medication intake; A history of seizures requiring medical treatment; A history of psychoactive substance abuse with inability to abstain, or presence of mental disorders; Patients with stable disease who decline surgical treatment; 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; 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; Pregnant or lactating women, and men or women of childbearing age who refuse to take appropriate contraceptive measures; Incapable of correctly understanding the content of questionnaires and unable to cooperate with researchers.