A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of PPGL (NCT05883085) | Clinical Trial Compass
UnknownPhase 2
A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of PPGL
China10 participantsStarted 2022-05-01
Plain-language summary
This phase II trial studies the effectiveness of anlotinib hydrochloride in the neoadjuvant therapy of locally advanced, or unresectable pheochromocytoma or paragangliom(PPGL). Anrotinib is used preoperatively in order to change unresectable tumors to resectable and reduce the high risk of surgery.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provide written informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
* The patient is diagnosed as pheochromocytoma or paraganglioma which is unresectable with R0 surgery, or extensive and thus maybe requiring resection of important organs, or with very high surgical risk.
* Laboratory requirements:
* Absolute granulocyte count (AGC) greater than 1.5 x 109/L;
* Platelet count greater than 80 x 109/L;
* Hemoglobin greater than 90g/L;
* Serum bilirubin less than 1.5 x upper limit of normal (ULN);
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN;
* Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min;
* Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
* Confirmed non-pregnancy and lactation. During the entire study period and within 6 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures.
Exclusion Criteria:
* Patients who have previously used other anti-vascular targeted drugs, such as sunitinib, bevacizumab, endurance, etc.
* Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery within 4 weeks prior to kinase inhibitor therapy.
* Patients with another primary malignancy within 5 years prior to starting study drug.
* Those who have multiple factors that affect oral medications (such as ina…
What they're measuring
1
The proportion of PPGL patients whose tumor change from unresectable to resectable tumor.
Timeframe: At the end of Cycle 4 (each cycle is 21 days)