SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma (NCT06323239) | Clinical Trial Compass
RecruitingPhase 2
SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma
China148 participantsStarted 2024-07-15
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 SBRT and LDRT 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:
* Diagnosed as recurrence/metastatic NPC
* Histopathological diagnosis of NPC(WHO II/III)
* ECOG 0-1 point
* No treatment to r/mNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy and chemoradiotherapy;
* At least one lesion could receive SBRT safely;
* Subject must have a measurable target lesion based on RECIST v1.1;
* Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/ L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
* Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Take effective contraceptions during and three months after treatment;
* Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
* Allergic to monoclonal antibodies, any PD-1 antibody components, gemcitabine and cisplatin;
* Unexplained fever \> 38.5 #, except for tumor fever;
* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy);
* Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive;
* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful…