Actively Recruiting
Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma
Led by Cancer Hospital of Guangxi Medical University · Updated on 2021-07-20
204
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.
CONDITIONS
Official Title
Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or two or more imaging exams (MRI and PET-CT) showing recurrent tumor
- Tumor staged as rT3-4N0-1M0 or rT1-4N2-3M0 according to the 8th AJCC edition
- ECOG performance status 0-1
- Neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 4 × 10^9/L, and hemoglobin ≥ 90 g/L
- Normal liver function (ALT, AST ≤ 2.5 × upper limit of normal, total bilirubin ≤ 1.5 × upper limit of normal)
- Normal renal function (creatinine clearance ≥ 60 ml/min)
- Signed informed consent form
- Male participants and females who are not pregnant
You will not qualify if you...
- Age younger than 18 or older than 65 years
- Positive hepatitis B surface antigen and HBV-DNA ≥ 200 IU/ml or 1000 cps/ml
- Positive hepatitis C antibody
- Active, known, or suspected autoimmune disease, except for type I diabetes, hypothyroidism requiring only hormone replacement, or certain skin diseases not requiring systemic therapy
- History of interstitial lung disease
- Use of prednisone ≥ 10 mg/day or other immunosuppressive treatments within 28 days prior to consent
- Receipt or planned receipt of live vaccine within 30 days prior to consent
- Women who are pregnant or breastfeeding
- History of malignant tumors within five years, except carcinoma in situ, papillary thyroid carcinoma, or non-melanoma skin cancer
- Hypersensitivity to macromolecular proteins or any component of Toripalimab
- HIV positive
- Severe uncontrolled medical conditions or infections
- Other diseases affecting safety or compliance, such as symptomatic heart failure, unstable angina, recent myocardial infarction, active infections needing systemic therapy, mental illness, or social/family factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Actively Recruiting
Research Team
S
Song Qu, PhD
CONTACT
Z
Zhong-Guo Liang, Master
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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