Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04778956
PHASE3

Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.

Official title: Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

218

Start Date

2021-03-03

Completion Date

2033-03-03

Last Updated

2021-03-04

Healthy Volunteers

No

Interventions

DRUG

Toripalimab

Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.

PROCEDURE

salvage surgery

Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.

Locations (7)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First People's Hospital of Foshan

Guangzhou, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

The Tenth Affiliated Hospital, Sun Yat-Sen University

Nanchang, Jiangxi, China