ClinicalTrials.gg
RecruitingNCT07907341Updated Oct 30, 2026

Safety and Efficacy of Belzutifan in Preoperative Preparation for Patients With Pheochromocytoma/Paraganglioma (PPGL)

A Phase 4 interventional study of Belzutifan in Pheochromocytoma and Paraganglioma (PPGL), sponsored by Longfei Liu,MD. Recruiting at 1 site in China. Open to participants aged 14 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Longfei Liu,MD · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
  • Started Apr 2026; still recruiting 7 months later.
Updated Oct 30, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
14 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pheochromocytoma and Paraganglioma (PPGL)

Keywords

  • pheochromocytoma and paraganglioma
  • belzutifan
03

In context

Pheochromocytoma

158 studies on the registry are indexed under Pheochromocytoma; 57 are open to participants now.

This study's planned enrollment of 20 is below the median of 37 across 87 interventional studies indexed under Pheochromocytoma.

Browse Pheochromocytoma studies →

Lead sponsor

This is the only study on the registry with Longfei Liu,MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. (ASA) physical status classification of Grade Ⅰ to Ⅲ.
  5. 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;
    • count > 80 × 10⁹/L;
    • (Hb) > 90 g/L;
    • Serum \< 1.5 × the (ULN);
    • Serum creatinine \< 1.5 × ULN or >= 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

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 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 ( (INR) > 1.5, or Prothrombin Time (PT) > (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 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 interval (QTc) >= 480 ms), and uncontrolled congestive heart failure of (NYHA) Grade >= 2;
    • 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 (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 (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.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Belzutifan group

    Drug: Belzutifan

Interventions

  • Belzutifan, 120 mg (3 × 40 mg) once daily for 5 consecutive days preoperatively, administered fasting or with a low- to moderate-fat diet.

06

What researchers measure

Primary outcomes

  1. plasma Metanephrines

    Time frame: Perioperative

Secondary outcomes

  1. Intraoperative blood pressure

    Time frame: Perioperative

  2. Intraoperative heart rate

    Time frame: Perioperative

  3. Intraoperative dosage of vasoactive agents

    Time frame: Perioperative

  4. Intraoperative fluid infusion volume

    Time frame: Perioperative

  5. Postoperative ICU admission rate

    Time frame: Perioperative

  6. Incidence of perioperative cardiovascular and cerebrovascular complications and mortality

    Time frame: Perioperative

  7. Postoperative use of vasoactive agents

    Time frame: Perioperative

  8. Postoperative blood MNs level

    Time frame: Perioperative

  9. Catecholamine levels in surgically resected tumor tissue

    The concentrations of catecholamines (epinephrine, norepinephrine, dopamine) within surgically resected pheochromocytoma/paraganglioma tumor tissue will be measured and compared between study groups.

    Time frame: Perioperative

  10. Safety evaluation of belzutifan

    Time frame: After patient discharge

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907341
Lead sponsor
Longfei Liu,MD
Responsible party
Longfei Liu,MD (Chief Physician, Department of Urology, Xiangya Hospital of Central South University) — Sponsor-investigator
First posted
Oct 30, 2026
Start date
Apr 1, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Chao Wang, Master
Contact
wangchao296@csu.edu.cn
+86 151 1103 1075
Longfei Liu, Doctor of Medicine
principal investigator · Xiangya Hospital of Central South University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Belzutifan

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