Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma.
Yuan Zhang, Lei Chen, Guo-Qing Hu...
https://pubmed.ncbi.nlm.nih.gov/31150573Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID06349889
Adebrelimab Combined with Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma A Phase 2 Multicenter Single-arm Clinical Trial
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
Researchers are evaluating the use of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy for patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC), specifically those with stage IVA+T3N2M0 disease. This phase 2, multicenter, single-arm study aims to understand the role of this combination treatment in this patient group. Participants receive three cycles of induction chemotherapy with gemcitabine and cisplatin, alongside Adebrelimab started on day 1 of induction therapy and given every three weeks for three cycles. This is followed by concurrent chemoradiotherapy with cisplatin and intensity-modulated radiotherapy. After radiation, patients receive nine cycles of adjuvant chemotherapy plus Adebrelimab every three weeks. During the study, patients will be closely monitored through clinical assessments, laboratory tests, and imaging to evaluate treatment response and safety. The primary outcome is failure-free survival measured over three years. The total involvement includes treatment and follow-up periods to assess effectiveness and safety of this combined therapy approach.
CONDITIONS
Official Title
Adebrelimab and Chemoradiotherapy in High-risk LANPC
Who Can Participate
Age: 18Years - 65Years
All Genders
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.
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1
2
3
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
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Research Team
J
Jun Ma, M.D.
L
Lei Chen, M.D.
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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