EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma (NCT06802835) | Clinical Trial Compass
RecruitingPhase 1/2
EGFR Antibody Combined With PD-1 Inhibitor and Chemotherapy in R/M Nasopharyngeal Carcinoma
China148 participantsStarted 2025-07-09
Plain-language summary
This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of EGFR antibody combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Patients with nasopharyngeal carcinoma who have recurred/metastasized after initial treatment or radical treatment;
* Age 18-75, male or female;
* Pathological diagnosis of nasopharyngeal carcinoma;
* ECOG score 0-1;
* Have not previously received any anti-tumor therapy such as radiotherapy, chemotherapy, immunotherapy or biotherapy for recurrence/metastasis;
* No contraindications of chemotherapy, immunotherapy and targeted therapy;
* At least 1 measurable lesion that meets RECIST 1.1 criteria;
* Blood routine examination standards should meet: WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥100×109/L, HGB≥90g/L (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct);
* Biochemical tests should meet the following criteria: TBIL≤2.0×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance ≥60ml/min (Cockcroft-Gault formula);
* Good coagulation function: defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as PT is within the intended range of anticoagulant drug use;
* The myocardial enzyme spectra were in the normal range;
* Women of childbearing age must already be using reliable contraception or have had a pregnancy test (serum or urine) within 7 days of enrollment with a negative result and be willing to use an effective method of contraception during the trial and for 3 mon…