- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Anli Tong
- Phone Number: 13911413589
- Email: tonganli@hotmail.com
Study Contact Backup
- Name: Yunying Cui
- Phone Number: 18365609818
- Email: cuiyunying@163.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Anli Tong
- Phone Number: 13911413589
- Email: tonganli@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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).
- 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.
- Participated in other clinical trials within 4 weeks.
- Patients are using drugs that interact with anlotinib.
- Any of the following: Pregnant women, Nursing women, Men or women of childbearing potential who are unwilling to employ adequate contraception.
- Patients with stable disease, and no desire for surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Anlotinib hydrochloride
Patients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14.
Courses repeat every 21 days
|
Patients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14.
Courses repeat every 21 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of PPGL patients whose tumor change from unresectable to resectable tumor.
Time Frame: At the end of Cycle 4 (each cycle is 21 days)
|
The proportion of PPGL patients whose tumor change from unresectable to resectable
|
At the end of Cycle 4 (each cycle is 21 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The objective response rate (ORR)
Time Frame: At the end of Cycle 4 (each cycle is 21 days)
|
Determined by the RECIST 1.1 criteria
|
At the end of Cycle 4 (each cycle is 21 days)
|
The ratio of tumor shrinkage
Time Frame: At the end of Cycle 4 (each cycle is 21 days)
|
The proportion of decrease in the sum of total size of the target lesions after treatment compared to before treatment.
|
At the end of Cycle 4 (each cycle is 21 days)
|
The biochemical response.
Time Frame: At the end of Cycle 4 (each cycle is 21 days)
|
An effective response of 24hCA, MNs meant that the concentration decreaseed by more than 40% than the baseline value or decreaseed to the normal range.
|
At the end of Cycle 4 (each cycle is 21 days)
|
R0 resection rate.
Time Frame: At the end of Cycle 4 (each cycle is 21 days)
|
The proportion of patients with surgical resection reached R0 resection
|
At the end of Cycle 4 (each cycle is 21 days)
|
Major pathological response rate (MPR).
Time Frame: At the end of Cycle 4 (each cycle is 21 days)
|
Defined as the remaining surviving tumor after surgical resection do not exceed 10% of the initial tumor tissue.
|
At the end of Cycle 4 (each cycle is 21 days)
|
Pathologic complete remission (pCR).
Time Frame: At the end of Cycle 4 (each cycle is 21 days)
|
There is no tumor cells microscopically.
|
At the end of Cycle 4 (each cycle is 21 days)
|
Safety of anlotinib treatment.
Time Frame: At the end of Cycle 1 (each cycle is 21 days)
|
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events.
|
At the end of Cycle 1 (each cycle is 21 days)
|
Collaborators and Investigators
Investigators
- Study Chair: Anli Tong, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06086-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pheochromocytoma
-
National Cancer Institute (NCI)RecruitingMetastatic Adrenal Gland Pheochromocytoma | Metastatic Paraganglioma | Unresectable Adrenal Gland Pheochromocytoma | Unresectable Paraganglioma | Advanced Adrenal Gland Pheochromocytoma | Advanced Paraganglioma | Stage III Adrenal Gland Pheochromocytoma and Sympathetic Paraganglioma AJCC v8 | Stage...United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Adrenal Gland Pheochromocytoma | Locally Advanced Paraganglioma | Metastatic Paraganglioma | Unresectable Adrenal Gland Pheochromocytoma | Unresectable Paraganglioma | Regional Adrenal Gland PheochromocytomaUnited States
-
Peking Union Medical College HospitalRecruitingPheochromocytoma, Metastatic | Paraganglioma, Malignant | Pheochromocytoma MalignantChina
-
Peking Union Medical College HospitalRecruitingUltrasonography | Pheochromocytoma, Metastatic | Paraganglioma, Malignant | Pheochromocytoma MalignantChina
-
Abramson Cancer Center of the University of PennsylvaniaCompletedUnresectable Paraganglioma | Recurrent Pheochromocytoma | Advanced Metastatic Paraganglioma | Advanced Metastatic Pheochromocytoma | Recurrent Paraganglioma | Unresectable PheochromocytomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedMetastatic Adrenal Gland Pheochromocytoma | Malignant Adrenal Gland Pheochromocytoma | Malignant ParagangliomaUnited States
-
Peking Union Medical College HospitalCompletedPheochromocytoma, Metastatic | Paraganglioma, Malignant | Pheochromocytoma MalignantChina
-
Peking Union Medical College HospitalRecruitingParaganglioma, Extra-Adrenal | Malignant Adrenal Gland Pheochromocytoma | Malignant Paraganglioma | Pheochromocytoma, Metastatic | Paraganglioma, MalignantChina
-
National Cancer Institute (NCI)TerminatedParaganglioma | Metastatic Adrenal Gland Pheochromocytoma | Recurrent Adrenal Gland Pheochromocytoma | Extra-Adrenal ParagangliomaUnited States, Singapore, Hong Kong
-
Kunwu Yan,MMCompletedHemodynamic | Adrenal Pheochromocytoma
Clinical Trials on Anlotinib hydrochloride
-
Peking Union Medical College HospitalRecruitingParaganglioma, Extra-Adrenal | Malignant Adrenal Gland Pheochromocytoma | Malignant Paraganglioma | Pheochromocytoma, Metastatic | Paraganglioma, MalignantChina
-
First People's Hospital of HangzhouChia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingRecurrent High-grade GliomaChina
-
Peng YuanCompletedBreast Neoplasm | Antineoplastic Agents | AnlotinibChina
-
Sun Yat-sen UniversityChia Tai Tianqing Pharmaceutical Group Co., Ltd.Recruiting
-
First Hospital of Shijiazhuang CityUnknownCarcinoma | Small Cell Lung Cancer | Lung NeoplasmChina
-
First Hospital of Shijiazhuang CityUnknownCarcinoma | Non-small Cell Lung Cancer | Lung NeoplasmChina
-
Peking Union Medical College HospitalRecruiting
-
Sun Yat-sen UniversityRecruitingSarcoma,Soft TissueChina
-
Peking University Third HospitalNot yet recruitingNon-Small Cell Lung Cancer
-
Zhejiang UniversityHuashan Hospital; West China Hospital; The First Affiliated Hospital of Zhengzhou... and other collaboratorsTerminatedHepatocellular CarcinomaChina