Actively Recruiting
EGFR Antibody Combined With Programmed Death-1 Inhibitor and Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Prospective, Multi-center, Phase I/II Clinical Trial
Led by Sun Yat-sen University · Updated on 2026-05-11
148
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
Z
Zhejiang Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and side effects of combining an EGFR antibody with a PD-1 antibody and chemotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma. This study is a prospective, single-arm, phase II clinical trial focused on this specific patient group to better understand treatment outcomes. The study is sponsored by Sun Yat-sen University. Participants will receive a combination of EGFR antibody, PD-1 antibody, and chemotherapy drugs (Gemcitabine and Cisplatin) for six cycles. The EGFR and PD-1 antibodies will continue as maintenance therapy for one year. Additionally, intensity-modulated radiation therapy (IMRT) may be applied to the primary tumor site. These treatments are delivered as part of a multi-center clinical trial. During the trial, participants will be closely monitored through various assessments including progression-free survival over one year, adverse events up to 16 months, overall survival, objective response rate, disease control rate, and quality of life measures. Laboratory tests, imaging, and clinical evaluations will be performed to track safety and treatment effects. The total duration of participation varies depending on the treatment and follow-up periods.
CONDITIONS
Brief Title
EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with nasopharyngeal carcinoma who have recurred or metastasized after initial or radical treatment
- Age between 18 and 75 years, male or female
- Pathological diagnosis of nasopharyngeal carcinoma
- ECOG performance status score of 0 or 1
- No prior anti-tumor therapy (radiotherapy, chemotherapy, immunotherapy, or biotherapy) for recurrence or metastasis
- No contraindications to chemotherapy, immunotherapy, or targeted therapy
- At least one measurable lesion meeting RECIST 1.1 criteria
- Blood tests within required limits: WBC ≥3.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L, HGB ≥90 g/L without recent transfusions or stimulating factors
- Biochemical tests within limits: TBIL ≤2.0×ULN, ALT and AST ≤2.5×ULN, BUN and creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min
- Good coagulation function (INR or PT ≤1.5×ULN) or controlled if on anticoagulants
- Normal myocardial enzyme levels
- Women of childbearing age must use reliable contraception or have a negative pregnancy test before enrollment and during the trial; men must use contraception during the trial and for 3 months after last PD-1 antibody dose
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Recurrence that can be treated with local surgery or radiotherapy
- Known allergy to investigational drugs or severe reactions to monoclonal antibodies
- Symptoms of central nervous system metastasis needing hormonal treatment
- Active infection or unexplained fever over 38.5°C at screening or before first dose
- Active or history of autoimmune diseases requiring intervention, except specific controlled conditions
- Immunodeficiency conditions such as HIV or active hepatitis B or C
- Previous or untreated other malignancies except certain skin or cervical cancers
- Uncontrolled cardiovascular diseases including significant heart ischemia, arrhythmias, or heart failure
- Recent major surgery complications not fully recovered
- Participation in another clinical study or recent use of investigational drugs
- Live vaccine use within 4 weeks before first dose
- Pregnant or breastfeeding women
- Other serious medical or social conditions that may affect safety or data collection
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 - 6 cycles for combined therapy plus maintenance for 1 year
Participants receive a combination of EGFR antibody, PD-1 antibody, and chemotherapy for 6 cycles, followed by maintenance therapy with EGFR and PD-1 antibodies for up to 1 year. Radiation therapy (IMRT) is also provided to the primary lesion.
Regular visits during 6 cycles and maintenance period
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
Z
Zhao Chong PhD.
M
Miao Jingjing MD.
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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