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
N/A
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 role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC), specifically those with stage IVA+T3N2M0 disease. This phase 2, multicenter, single-arm clinical trial aims to study treatment outcomes including failure-free survival over 3 years. Participants receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin every 3 weeks before radiation treatment. Concurrent cisplatin is given during intensity-modulated radiotherapy (IMRT) which delivers a total dose of 6996 cGy in 33 fractions. Adebrelimab, a PD-L1 antibody, is administered at 1200 mg every 3 weeks starting on day 1 of induction chemotherapy and continues for 3 cycles during induction and 9 cycles during adjuvant chemotherapy. During the study, participants will undergo multiple assessments including monitoring for adverse events, quality of life evaluations, and measurements of overall survival, distant metastasis-free survival, and locoregional recurrence-free survival over 3 years. Researchers will track failure-free survival as the primary outcome. The study includes regular follow-up visits to assess treatment effects and safety during and after therapy.
CONDITIONS
Brief 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 edition).
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate bone marrow function: neutrophil count 1.5 x 10^9/L, hemoglobin 90 g/L, platelet count 100 x 10^9/L.
- Liver function with ALT/AST 2.5 times upper limit of normal and bilirubin 1.5 times upper limit of normal.
- Adequate kidney function with creatinine clearance rate 60 ml/min.
- Written informed consent given after understanding the investigational nature.
- Willingness to use effective contraception during treatment and for 1 year after if sexually active (both women of childbearing potential and men).
You will not qualify if you...
- Age younger than 18 or older than 65 years.
- Positive hepatitis B surface antigen with high viral load.
- Positive hepatitis C antibody.
- Active autoimmune disease requiring systemic treatment, except controlled type I diabetes, hypothyroidism, or mild skin diseases.
- Use of systemic corticosteroids over prednisone 10 mg/day or other immunosuppressants within 28 days before consent.
- Active tuberculosis within the past year.
- History of interstitial lung disease.
- Recent live vaccination within 30 days before consent or planned live vaccination soon.
- Pregnancy or breastfeeding.
- Prior malignancy within 5 years except certain non-invasive or treated cancers.
- Allergy to large protein products or components of Adebrelimab.
- Known HIV infection.
- Any condition that may interfere with consent, participation, or result interpretation as judged by the investigator.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 39 weeks covering induction, concurrent chemoradiotherapy, and adjuvant therapy
Participants receive induction chemotherapy with gemcitabine and cisplatin every 3 weeks for 3 cycles, concurrent cisplatin with radiation, and adjuvant chemotherapy combined with Adebrelimab administered every 3 weeks during induction and adjuvant phases.
Multiple visits every 3 weeks for drug administration and radiation sessions over the treatment period
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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