Actively Recruiting
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT
Led by Fudan University · Updated on 2022-11-29
198
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nasopharyngeal carcinoma is biologically different from traditional head and neck squamous cell carcinoma. The mainstay treatment for locally advanced nasopharyngeal carcinoma is cisplatin-based concurrent chemoradiation. Recent phase III randomized control trials have demonstrated that induction chemotherapy plus concurrent chemoradiation further improved progression-free survival. However, not every patient has good response to induction chemotherapy. Evidence has accumulated that those with poor response to induction chemotherapy, or those with detectable Epstein-Barr Virus (EBV) DNA post induction chemotherapy, correlated with poorer progression-free survival. Huang CL et al. (Int J Radiat Oncol Bio Phys. 2019) reported that plasma EBV DNA load at completion of induction chemotherapy was an independent and earlier predictor for progression-free survival and overall survival in locally advanced nasopharyngeal carcinoma. Lv J et al. (Nat Commun. 2019) demonstrated that real-time monitoring of plasma EBV DNA response added prognostic information, and had the potential uitility for risk-adapted treatment intensification in nasopharyngeal carcinoma. Therefore, investigators selects those with poor plasma EBV DNA response during and after induction chemotherapy, and intensifies the treatment with combination of anti-PD-1 antibody, in order to improve progression-free survival in locally advanced nasopharyngeal carcinoma, according to response-adapted strategy.
CONDITIONS
Official Title
Modulation Therapy for Locally Advanced NPC Based on Plasma EBV DNA Level Post-ICT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and ability to comply with study visits and procedures
- Age between 18 and 70 years
- Newly diagnosed, pathologically confirmed primary non-keratinizing nasopharyngeal carcinoma
- Locally advanced stage (T3-4N0-1M0 or TanyN2-3M0) based on AJCC 8th edition
- Detectable EBV DNA before treatment
- ECOG performance status 0-1
- No prior treatment for nasopharyngeal carcinoma
- Normal bone marrow function: white blood cells >410^9/L, neutrophils >1.510^9/L, hemoglobin >90g/L, platelets >100*10^9/L
- Normal liver and kidney function within specified limits
- For hepatitis B positive patients, HBV DNA <2500 copies/ml; for hepatitis C antibody positive, HCV RNA negative
- Agreement to use reliable contraception from screening through one year post-treatment
You will not qualify if you...
- Pathologically confirmed keratinizing carcinoma or basaloid squamous cell carcinoma
- Previous or current other cancers except treated non-melanoma skin cancer, cervical carcinoma in situ, or papillary thyroid carcinoma
- Undetectable plasma EBV DNA before treatment
- Prior radiation therapy overlapping current nasopharyngeal carcinoma treatment area
- Prior surgery (except biopsy), biological therapy, chemotherapy, or immunotherapy before enrollment
- Current participation in other interventional trials or recent immunosuppressive therapy or live vaccines
- Recent surgery or trauma within 30 days before screening
- Uncontrolled heart disease or recent serious cardiac events
- Stroke within 6 months
- Severe active infection requiring systemic treatment within 30 days
- Active autoimmune diseases except specified exceptions
- Positive HIV or other immunodeficiency diseases
- Interstitial lung disease or recent pneumonia requiring steroids
- Active or recent tuberculosis infection
- Positive hepatitis B surface antigen with high HBV DNA or positive hepatitis C RNA
- Pregnant or breastfeeding women
- Other serious illnesses or conditions that could affect safety or compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan Universtiy Shanghai Cancer Centre
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Chao-su Hu, M.D.
CONTACT
X
Xiaomin Ou, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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