Not Yet RecruitingPhase 2

Anlotinib Combined With Benmelstobart for Advanced Pheochromocytoma

China22 participantsStarted 2025-05-01

Plain-language summary

There is currently no standard first-line treatment for stage PPGL, and the 5-year survival rate of patients with advanced pheochromocytoma/paraganglioma (PPGL) is low, ranging from 30% to 60%. At present, several domestic teams have carried out clinical studies on the treatment of advanced PPGL with good efficacy. In the early stage, our center used anrotinib to treat advanced PPGL, and the overall effective rate reached 44%. In the early stage, our team used anrotinib combined with PD-1 monoclonal antibody to treat advanced PPGL patients. The effective rate reached 66% (2/3). Therefore, the investigators plan to further conduct prospective studies to explore the efficacy and safety of anlotinib combined with PD-1 monoclonal antibody in the treatment of advanced PPGL, so as to bring benefits to patients with advanced PPGL.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Blood routine examination:
✓. Blood clotting test:

Exclusion criteria

✕. Clinically significant hemoptysis (\> 50ml daily hemoptysis) occurred within 3 months prior to enrollment; Or clinically significant bleeding symptoms or definite bleeding tendencies, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, stool occult blood or above at baseline, or vasculitis;
✕. hypertension, which is not well controlled by antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100mmHg); In the 6 months prior to randomization, the following conditions had occurred: myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supracentricular or ventricular arrhythmias, and symptomatic congestive heart failure;
✕. interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as poorly controlled diabetes (fasting blood glucose (FBG) \> 10mmol/ L), pulmonary fibrosis and acute pneumonia, etc.); Renal failure requires hemodialysis or peritoneal dialysis; Liver cirrhosis, decompensated liver disease, active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower detection limit of analytical methods) or chronic hepatitis requiring antiviral therapy;

What they're measuring

Objective response rate

Timeframe: 2years

Trial details

NCT IDNCT06429397

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01

Contact for this trial

Fangjian Zhou, Doctor

13922735659 zhoufj@sysucc.org.cn

View on ClinicalTrials.gov More Pheochromocytoma trials