Actively Recruiting
Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2022-04-25
556
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
T
Tongji Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial is aimed to investigate whether additional adjuvant PD-1 antibody treatment could improve survival in high-risk nasopharyngeal carcinoma compared to metronomic capecitabine alone.
CONDITIONS
Official Title
Metronomic Capecitabine With or Without PD-1 Antibody as Adjuvant Therapy in High-risk Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old
- Pathologically confirmed primary nasopharyngeal carcinoma with non-keratinizing carcinoma
- Locoregionally advanced nasopharyngeal carcinoma (T4N+ or TanyN2-3M0) or high pretreatment EBV DNA (≥ 4000 copies/mL)
- Completed induction and concurrent chemoradiotherapy with recommended regimen
- ECOG performance status of 0 to 1
- Begin adjuvant therapy within 1 month after last radiotherapy, no later than 6 weeks
- Normal bone marrow function with specified white blood cell, hemoglobin, and platelet counts
- Normal liver and kidney function within specified laboratory limits
- Signed informed consent and willingness to comply with study visits and procedures
- Use reliable contraception during screening and 1 year after treatment if of childbearing potential
You will not qualify if you...
- Positive hepatitis B surface antigen with high viral load or positive hepatitis C antibody
- Positive HIV antibody or diagnosis of AIDS
- Conditions interfering with oral medication (e.g., dysphagia, chronic diarrhea, bowel obstruction)
- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral treatment
- Active or suspected autoimmune diseases, except specified exceptions
- Interstitial lung disease or pneumonia requiring steroid therapy within 1 year
- Evidence of persistent local disease or distant metastasis after chemoradiotherapy
- Use of systemic immunosuppressive therapy above specified doses within 28 days prior to consent
- Uncontrolled heart disease including heart failure, unstable angina, recent myocardial infarction, or arrhythmias requiring treatment
- Pregnant or breastfeeding women
- Previous or current malignancies except certain treated skin and thyroid cancers
- Recent live vaccine within 30 days before first dose of tislelizumab
- History of organ transplantation
- Other serious illnesses or conditions affecting safety or compliance
- Prior surgical treatment, biological therapy, or immunotherapy during or before radiotherapy
- Current or planned chemotherapy, biological therapy, or immunotherapy outside study
- History of severe hypersensitivity to monoclonal antibodies
- Prior chemotherapy or surgery before standard treatment
- Prior radiation therapy except for specified exceptions
- Known intolerance or sensitivity to study medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
J
Jun Ma, MD
CONTACT
Y
Yuan Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here