The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma.
The purpose of this study was to explore whether the efficacy and survival time of patients with local advanced primary salivary gland adenocarcinoma could be further improved through the treatment of Surufatinib neoadjuvant for local advanced primary salivary gland adenocarcinoma, and to explore the safety and tolerability of this regimen.A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma:a Single-arm, Prospective,Open Label Study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients receive oral Surufatinib at a dose of 300mg/d (once-daily dosing continuously, every 28-day treatment cycle), A total of 2 cycles were performed, and efficacy evaluation was performed at the end of each cycle or was determined to be required by the investigator. If disease progression or unacceptable toxicity occurred during the period, induction therapy was terminated early, and after corresponding treatment, surgical treatment was entered as early as possible. Surufatinib treatment was interrupted 4-7 days before surgical treatment to maintain organ function; Note: Postoperative radiotherapy or chemoradiotherapy is permitted after radical surgery at the discretion of the investigator.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China
RECRUITINGObjective response rate (ORR)
CR + PR rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Major pathological response rate (MPR)
the reduction of the active tumor below an established clinically significant node.
Time frame: up to 12 months
Progression Free Survival (PFS)
To assess the efficacy of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas, patients by assessment of progression free survival (PFS) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Time frame: up to 36 months
Assess the anti-tumor activity:DCR
Disease control rate (DCR):CR + PR + SD rate according to the RECIST version 1.1 guidelines.
Time frame: up to 12 months
Overall survival time
OS was calculated from the date of pharmacy to death from any cause.
Time frame: through study completion, an average of 1 year
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