Actively Recruiting
Adebrelimab and Chemoradiotherapy in High-risk LANPC
Led by Sun Yat-sen University · Updated on 2025-01-15
50
Participants Needed
4
Research Sites
196 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
N
Nanfang Hospital, Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC).
CONDITIONS
Official Title
Adebrelimab and Chemoradiotherapy in High-risk LANPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed nasopharyngeal carcinoma.
- Tumor staged as IVA+T3N2M0 (AJCC 8th).
- Eastern Cooperative Oncology Group performance status 1 or less.
- Adequate marrow function: neutrocyte count at least 1.5 x 10^9/L, hemoglobin at least 90 g/L, and platelet count at least 100 x 10^9/L.
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) levels no more than 2.5 times the upper limit of normal, and bilirubin no more than 1.5 times the upper limit of normal.
- Adequate kidney function with creatinine clearance rate at least 60 ml/min.
- Patients must give written informed consent after being informed about the investigational nature of the study.
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during treatment and for 1 year after the last dose.
You will not qualify if you...
- Age under 18 or over 65.
- Positive for hepatitis B surface antigen with hepatitis B virus DNA over 1 x 10^3 copies/ml or 200 IU/ml.
- Positive for hepatitis C virus antibody.
- Active autoimmune disease requiring systemic treatment, except type I diabetes, hypothyroidism treated with replacement therapy, or certain skin diseases not needing systemic treatment.
- Use of systemic corticosteroids equivalent to prednisone over 10 mg/day or other immunosuppressive therapy within 28 days before consent.
- History of active tuberculosis within the past year.
- History of interstitial lung disease.
- Receipt of live vaccine within 30 days before consent or planned live vaccine use soon.
- Pregnant or breastfeeding women.
- Diagnosis of another malignancy within 5 years, except certain treated cancers.
- Known allergy to Adebrelimab or its components.
- Known HIV infection.
- Any other medical or social condition that could interfere with study participation or result interpretation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
2
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
4
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
J
Jun Ma, M.D.
CONTACT
L
Lei Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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