Actively Recruiting
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2021-03-04
218
Participants Needed
7
Research Sites
626 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrence occurred more than 6 months after finishing radiotherapy
- Histologically confirmed recurrent nasopharyngeal carcinoma
- Resectable nasopharyngeal tumor classified as recurrent T1, T2, or T3 according to AJCC 8th edition
- Resectable recurrent regional lymph node disease (recurrent N1-3) without involvement of prevertebral fascia, cervical vertebrae, or carotid arteries
- Provided written informed consent
You will not qualify if you...
- Karnofsky Performance Status less than 70
- Severe medical disorders, important organ dysfunction, or substantial history of mental illness
- Presence of other known malignant tumors
- Participation in other drug trials within 3 months prior to planned treatment
- Received systemic or local glucocorticoid therapy within 4 weeks prior to planned treatment
- Need for long-term immunosuppressive drugs or immunosuppressive-dose glucocorticoid therapy
- Prior treatment with PD-1, PD-L1, or CTLA-4 agents
- Active autoimmune diseases requiring therapy, except certain skin diseases
- Known HIV infection, positive hepatitis B with high viral load, or positive hepatitis C antibody
- Received live vaccine within 4 weeks prior to planned treatment
- Pregnancy or breastfeeding
- Inability to complete regular follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
3
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
4
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510700
Not Yet Recruiting
5
The First People's Hospital of Foshan
Guangzhou, Guangdong, China, 528000
Not Yet Recruiting
6
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403
Not Yet Recruiting
7
The Tenth Affiliated Hospital, Sun Yat-Sen University
Nanchang, Jiangxi, China, 330008
Not Yet Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
CONTACT
Y
You-Ping Liu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here