Actively Recruiting
Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
Led by Jiangxi Provincial Cancer Hospital · Updated on 2024-03-07
22
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to explore the efficacy and safety of a combination regimen of Anti-PD1 monoclonal antibody, nimotuzumab, and capecitabin in treating recurrent or metastatic nasopharyngeal carcinoma patients who have failed first-line platinum-based chemotherapy.
CONDITIONS
Official Title
Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma not suitable for surgery or radiation
- Failed first-line platinum-based chemotherapy with disease progression during or after treatment, or recurrence/metastasis within 6 months after platinum chemoradiation
- Age between 18 and 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- At least one measurable lesion according to RECIST v1.1 criteria
- Adequate organ function based on specific blood counts, liver and kidney function tests, and thyroid hormone levels without recent blood transfusion or growth factor support
- Negative pregnancy test for women with fertility potential
- Written informed consent obtained
You will not qualify if you...
- History of severe immediate allergy to drugs used in this study
- Previous treatment with anti-EGFR or anti-PD-1 monoclonal antibodies
- Presence of other malignant tumors
- Certain serious cardiovascular events or conditions within 6 months before screening
- Recent use (within 4 weeks) of investigational drugs, large doses of immunosuppressants, anti-tumor vaccines, or live vaccines
- Major surgery or serious trauma within 4 weeks before first study drug use
- Participation in another clinical study except observational or follow-up studies
- Active or relapsing autoimmune diseases (except controlled conditions listed)
- Active infections including tuberculosis, hepatitis B or C, or HIV
- History or evidence of lung diseases such as idiopathic pulmonary fibrosis or pneumonia
- Legal incapacity or limited civil capacity
- Drug abuse, alcohol addiction, or mental illness affecting study understanding
- Immunodeficiency or HIV/AIDS diagnosis
- Pregnancy or lactation, or unwillingness/inability to use contraception during and 1 year after study
- Recurrent nasopharyngeal carcinoma suitable for surgical treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Nasopharyngeal Carcinoma, Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
Research Team
J
Jingao Li, MD
CONTACT
X
Xiaochang Gong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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