Actively Recruiting
Efficacy and Safety of Anti-PD1 Monoclonal Antibody Combined With Nimotuzumab and Capecitabine in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma: A Single-arm, Open-label, Multi-center Phase II Clinical Trial
Led by Jiangxi Provincial Cancer Hospital · Updated on 2024-03-07
22
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment using an anti-PD1 monoclonal antibody, nimotuzumab, and capecitabine in patients with recurrent or metastatic nasopharyngeal carcinoma who have not responded to first-line platinum-based chemotherapy. This Phase II clinical trial aims to provide new evidence for personalized comprehensive treatment in this patient group, addressing the current lack of standard options after initial treatment failure. The treatment involves an initial phase with intravenous anti-PD1 monoclonal antibody drugs such as toripalimab, camrelizumab, or tislelizumab every three weeks, weekly intravenous nimotuzumab for six cycles starting with a 400 mg dose, and oral capecitabine twice daily for two weeks in each three-week cycle. In the maintenance phase, anti-PD1 antibodies and nimotuzumab are given every three weeks, alongside continued capecitabine, for up to one year or until disease progression, intolerable side effects, patient withdrawal, or investigator decision. Participants will be closely monitored through regular assessments including measuring tumor response using RECIST criteria, evaluating disease control, survival rates, and adverse events over periods of up to two years. The study includes detailed eligibility screening to confirm diagnosis, organ function, and life expectancy. Researchers will track treatment safety and effectiveness throughout the trial, which may last until one year of treatment plus follow-up through August 2026.
CONDITIONS
Brief 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 curative surgery or radiation
- Failure of first-line platinum-based chemotherapy with disease progression during or within 6 months after treatment
- 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 without recent blood transfusion or growth factor support
- Negative pregnancy test for women with fertility potential
- Signed informed consent
You will not qualify if you...
- History of severe allergic reaction to study drugs
- Prior treatment with anti-EGFR monoclonal antibodies or anti-PD-1 monoclonal antibodies
- Presence of other malignant tumors
- Major cardiovascular events or severe heart conditions within 6 months before screening
- Recent use of investigational drugs, immunosuppressants, or live vaccines within 4 weeks before treatment
- Major surgery or serious trauma within 4 weeks before first study drug administration
- Participation in other clinical studies except observational or follow-up studies
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Active infections including tuberculosis, hepatitis B or C, or HIV, unless controlled
- History or evidence of specific lung diseases or active pneumonia
- Limited legal capacity or inability to understand study risks
- Drug or alcohol addiction or severe mental illness
- Known immunodeficiency or HIV/AIDS diagnosis
- Pregnancy, lactation, or unwillingness to use contraception during and for 1 year after treatment
- Recurrent nasopharyngeal carcinoma suitable for surgical treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or until intolerable toxic reactions, disease progression, withdrawal of consent, or investigator decision
Participants receive a combination treatment of anti-PD1 monoclonal antibody, nimotuzumab, and capecitabine. The first 6 cycles include intravenous anti-PD1 antibody every 3 weeks, nimotuzumab intravenous infusion weekly (with a higher first dose), and oral capecitabine twice daily on days 1-14 every 3 weeks. Following this, maintenance treatment continues with anti-PD1 antibody and nimotuzumab intravenous infusion every 3 weeks, and capecitabine oral chemotherapy on the same schedule.
Weekly visits for nimotuzumab infusion during first 6 cycles, then visits every 3 weeks during maintenance
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
X
Xiaochang Gong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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