NCT05013515

Efficacy and Safety of Neoadjuvant Surufatinib for Patients With Salivary Gland Carcinomas

A Study of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma：a Single-arm, Prospective,Open Label Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective is to investigate the efficacy and safety of Surufatinib Neoadjuvant Therapy for Locally Advanced Primary Saliary Gland Adenocarcinoma.

Detailed description

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.

Conditions

• Salivary Gland Carcinomas

Interventions

Type	Name	Description
DRUG	Surufatinib	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.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-09-01
• Completion: 2024-06-01
• First posted: 2021-08-19
• Last updated: 2021-08-19

Locations

1 site across 1 country: China