PheochromocytomaPhase 2NCT05883085
A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of PPGL
A Phase 2 study testing Anlotinib hydrochloride in people with Pheochromocytoma and Paraganglioma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pheochromocytoma, Paraganglioma
- What is being tested?
- Anlotinib hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Anli Tong, 13911413589, tonganli@hotmail.com
About this study
Official title: A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of Locally Advanced, or Unresectable Pheochromocytoma or Paraganglioma
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.
Read the 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
- Being tested
- Anlotinib hydrochloride
- Keywords
- Pheochromocytoma or Paraganglioma, Neoadjuvant Treatment, Anlotinib
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochlorideDrug
Also called Anlotinib
Patients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14. Courses repeat every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib hydrochloride | Other | Patients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14. Courses repeat every 21 days Receives: Drug: Anlotinib hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of Cycle 4 (each cycle is 21 days)
Secondary outcomes (7)
The objective response rate (ORR)
Determined by the RECIST 1.1 criteria
Measured: At the end of Cycle 4 (each cycle is 21 days)
The ratio of tumor shrinkage
The proportion of decrease in the sum of total size of the target lesions after treatment compared to before treatment.
Measured: At the end of Cycle 4 (each cycle is 21 days)
The biochemical response.
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.
Measured: At the end of Cycle 4 (each cycle is 21 days)
R0 resection rate.
The proportion of patients with surgical resection reached R0 resection
Measured: At the end of Cycle 4 (each cycle is 21 days)
Major pathological response rate (MPR).
Defined as the remaining surviving tumor after surgical resection do not exceed 10% of the initial tumor tissue.
Measured: At the end of Cycle 4 (each cycle is 21 days)
Pathologic complete remission (pCR).
There is no tumor cells microscopically.
Measured: At the end of Cycle 4 (each cycle is 21 days)
Safety of anlotinib treatment.
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 May 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anli Tong, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883085
- Sponsor's protocol ID
- 06086-02
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety and Effectiveness of Anlotinib for Neoadjuvant Treatment of Locally Advanced, or Unresectable Pheochromocytoma or Paraganglioma
- ClinicalTrials.gov ID
- NCT05883085
- Acronym / sponsor ID
- 06086-02
- Conditions
- Pheochromocytoma, Paraganglioma
- Keywords
- Pheochromocytoma or Paraganglioma, Neoadjuvant Treatment, Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib hydrochloride | Other | Drug: Anlotinib hydrochloridePatients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14. Courses repeat every 21 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib hydrochlorideAlso: AnlotinibPatients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14. Courses repeat every 21 days | Drug | Anlotinib hydrochloride |
Primary outcome
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
7 secondary outcomes
The objective response rate (ORR)
Time frame: 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 biochemical response.
Time frame: 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)
Major pathological response rate (MPR).
Time frame: 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)
Safety of anlotinib treatment.
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anli Tong study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib hydrochloride in people with Pheochromocytoma and Paraganglioma, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anli Tong (13911413589, tonganli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.