Actively Recruiting
Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2020-09-28
226
Participants Needed
6
Research Sites
364 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
A
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.
CONDITIONS
Official Title
Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed recurrent nasopharyngeal carcinoma
- Recurrence occurred more than 12 months after the first radiotherapy course
- Tumor stage rT2-4N0-3M0, rII-IVa according to the 8th AJCC edition
- Measurable disease by CT or MRI using RECIST 1.1 criteria
- Karnofsky performance score of 70 or higher
- Normal bone marrow function
- Normal liver and kidney function, including total bilirubin, AST, ALT no more than 2.5 times upper normal limit and creatinine clearance at least 60 mL/min or creatinine no more than 1.5 times upper normal limit
- Provided written informed consent
You will not qualify if you...
- Resectable nasopharyngeal disease of stages rT2 or rT3 as defined by tumor location and distance from carotid artery
- Severe nasopharyngeal necrosis, radiation-induced brain injury, or neck fibrosis deemed unsuitable for secondary radiotherapy
- Known allergies to large molecule protein products or any study therapy components
- Presence of other malignant tumors
- Active or history of autoimmune diseases
- History of psychiatric substance abuse, alcoholism, or drug addiction
- Laboratory values not meeting study standards within 7 days before enrollment
- Use of systemic glucocorticoid therapy within 4 weeks before first study medication dose
- Active tuberculosis within past year or inadequately treated TB
- Prior treatment with PD-1, anti-PD-L1, or CTLA-4 agents
- Active autoimmune diseases requiring systemic treatment, except certain skin diseases
- Known HIV infection
- Positive hepatitis B surface antigen with high HBV DNA or positive hepatitis C antibody
- Receipt of live vaccine within 4 weeks before starting study therapy
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Not Yet Recruiting
3
Yuebei People's Hospital
Shaoguan, Guangdong, China, 512025
Not Yet Recruiting
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403
Not Yet Recruiting
5
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Not Yet Recruiting
6
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543002
Actively Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
CONTACT
R
Rui You, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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