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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients receive anlotinib hydrochloride 8-12mg orally once daily on days 1-14. Courses repeat every 21 days
Peking Union Medical College Hospital
Beijing, China
RECRUITINGThe proportion of PPGL patients whose tumor change from unresectable to resectable tumor.
The proportion of PPGL patients whose tumor change from unresectable to resectable
Time frame: At the end of Cycle 4 (each cycle is 21 days)
The objective response rate (ORR)
Determined by the RECIST 1.1 criteria
Time frame: 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.
Time frame: 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.
Time frame: At the end of Cycle 4 (each cycle is 21 days)
R0 resection rate.
The proportion of patients with surgical resection reached R0 resection
Time frame: 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.
Time frame: At the end of Cycle 4 (each cycle is 21 days)
Pathologic complete remission (pCR).
There is no tumor cells microscopically.
Time frame: At the end of Cycle 4 (each cycle is 21 days)
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Safety of anlotinib treatment.
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events.
Time frame: At the end of Cycle 1 (each cycle is 21 days)