Prediction and Evaluation of Anlotinib Treatment Response Using Contrast Enhanced Ultrasound PPGL Patients

Study Purpose

Anlotinib is a multi-target receptor tyrosine kinase inhibitor (TKI) targeting tumor angiogenesis and growth. The purpose of this study is to evaluate the efficiency of contrast enhanced ultrasound in assessing effectiveness of anlotinib in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma(PPGL).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 18 years of age or older.
  • - Provide written informed consent.
  • - Willing to return to enrolling institution for follow-up.
  • - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • - Life expectancy > 3 months.
  • - Patients diagnosis with pheochromocytoma or paraganglioma will received anlotinib treatment.
  • - 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%).

Exclusion Criteria:

  • - Patients who are allergic to ultrasound contrast agents.
  • - Any of the following:Pregnant women,Nursing women,Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • - 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.).
  • - Patients with known untreated brain metastases are excluded.
Patients having a history of brain metastasis that have been previously irradiated or resected greater than 2 months prior to enrollment and are clinically and radiographically stable will be considered for enrollment. Patients with brain metastases with symptoms or symptom control for less than 2 months.
  • - 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).
Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment.
  • - Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders.
  • - Imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study.
  • - Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before enrollment, patients with any bleeding or bleeding event ≥ CTCAE grade 3, unhealed wounds, ulcers or fractures.
  • - Patients are using drugs that interact with Anlotinib.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06015061
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Peking Union Medical College Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anli Tong
Principal Investigator Affiliation Peking Union Medical College Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pheochromocytoma, Metastatic, Ultrasonography, Paraganglioma, Malignant, Pheochromocytoma Malignant
Additional Details

Contrast-enhanced ultrasound (CEUS) is a non-invasive and efficient imaging technique which can observe the blood flow at the tissue perfusion level with microbubble contrast agents and obtain information about tumor perfusion. There have been several studies demonstrating the utility of CEUS for early prediction of response to neoadjuvant chemotherapy in breast cancer, pancrearic cancer as well as lymphoma. However, few studies have reported the use of CEUS for the evaluation of therapeutic response in PPGL. What quantitative parameters of CEUS can early reflect the neovascular changes after treatment with anlotinib in patients with locally advanced, metastatic, or unresectable PPGL? The aim of our study is to evaluate the parameters for CEUS imaging and the therapeutic response of PPGL before and after anlotinib therapy and to determine the most useful CEUS response parameters.

Arms & Interventions

Arms

: Pheochromocytoma or Paraganglioma Patients with Anlotinib Treatment

to evaluate the efficiency of contrast enhanced ultrasound in assessing effectiveness of anlotinib in patients with locally advanced, metastatic, or unresectable pheochromocytoma or paraganglioma(PPGL).

Interventions

Diagnostic Test: - Contrast-enhanced ultrasound(CEUS)

CEUS is a quantitative kinetic imaging modality that can assess intravascular blood flow in PPGL tumors.

Contact a Trial Team

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International Sites

Peking Union Medical College Hospital, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, ,

Site Contact

Anli Tong

[email protected]

13911413589

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