NCT05883085

A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of PPGL

A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of Locally Advanced, or Unresectable Pheochromocytoma or Paraganglioma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective, single arm phase II study is designed to evaluate the efficacy of neoadjuvant therapy with anlotinib hydrochloride in locally advanced,or unresectable PPGL patients. Locally advanced,or unresectable PPGL patients receive anlotinib hydrochloride(10-12mg orally once daily on days 1-14, courses repeat every 21 days). Imaging examinations will be conducted after 4 courses to re-evaluate the surgical possibility. If the patient's tumor shrinks after 4 courses but is still unresectable, the patients will continue antirotinib therapy for another 4 courses. PRIMARY OBJECTIVES: The proportion of patients whose PPGL change from unresectable to resectable tumor. SECONDARY OBJECTIVES: To determine the objective response rate (ORR) . To determine the ratio of tumor shrinkage. To determine the biochemical response . To determine the R0 resection rate. To determine the Major pathological response rate (MPR). To determine the pathologic complete remission（pCR). To assess the safety of anlotinib treatment.

Conditions

• Pheochromocytoma
• Paraganglioma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride	Patients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14. Courses repeat every 21 days

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-12-01
• Completion: 2024-05-01
• First posted: 2023-05-31
• Last updated: 2023-05-31

Locations

1 site across 1 country: China