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

NCT05883085 | Unknown Phase 2

• 1 other identifier: 06086-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pheochromocytoma; Paraganglioma

Keywords

Pheochromocytoma or Paraganglioma; Neoadjuvant Treatment; Anlotinib

Outcome Measures

Primary Outcomes (1)

• The proportion of PPGL patients whose tumor change from unresectable to resectable tumor.

  The proportion of PPGL patients whose tumor change from unresectable to resectable

  At the end of Cycle 4 (each cycle is 21 days)

Secondary Outcomes (7)

• The objective response rate (ORR)

  At the end of Cycle 4 (each cycle is 21 days)

• The ratio of tumor shrinkage

  At the end of Cycle 4 (each cycle is 21 days)

• The biochemical response.

  At the end of Cycle 4 (each cycle is 21 days)

• R0 resection rate.

  At the end of Cycle 4 (each cycle is 21 days)

• Major pathological response rate (MPR).

  At the end of Cycle 4 (each cycle is 21 days)

Study Arms (1)

Anlotinib hydrochloride

OTHER

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

Drug: Anlotinib hydrochloride

Interventions

Anlotinib hydrochloride DRUG

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

Also known as: Anlotinib

Anlotinib hydrochloride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
• Active or uncontrolled intercurrent illness including, but not limited to:
• Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥100 mmHg);
• Patients with uncontrolled myocardial ischemia or myocardial infarction, arrhythmia (including QTC≥480ms), and uncontrolled congestive heart failure，grade ≥2（New York Heart Association ）;
• Ongoing or active infection;
• Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment;
• Renal failure requires hemodialysis or peritoneal dialysis;
• Have a history of immunodeficiency, including HIV or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Diabetes is poorly controlled (fasting blood glucose (FBG)\> 10mmol/L);
• Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein content is confirmed to be greater than 1.0 g;
• Patients who have seizures and need treatment;
• Any of the following conditions ≤ 6 months prior to registration: Cerebrovascular accident (CVA) or transient ischemic attack (TIA); Serious or unstable cardiac arrhythmia; Pulmonary embolism, untreated deep venous thrombosis (DVT).

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Anli Tong

  Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Anli Tong

CONTACT

13911413589; tonganli@hotmail.com

Yunying Cui

CONTACT

18365609818; cuiyunying@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 31, 2023
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-04

Locations

CN (1)