Phase
Condition
Carcinoma
Nasopharyngeal Cancer
Treatment
radiation
Toripalimab
Gemcitabine
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntarily participate in and sign informed consent in person.
Age 18-65, male or non-pregnant female.
Pathological diagnosis of nasopharyngeal non-keratonic carcinoma (differentiated orundifferentiated, i.e., WHO type II or III).
First treatment patients who did not receive antitumor therapy had no history ofother malignant tumors;
Stage IVa: TanyN3M0/T4N0-2M0 (8th AJCC/UICC stage)
ECOG score 0-1, no serious dysfunction of heart, lung, liver, kidney and other vitalorgans.
Hemoglobin (HGB) ≥90 g/L, white blood cells (WBC) ≥4.0×109 /L, platelets (PLT) ≥100×109 /L.
Liver function: ALT and AST< 2.5 times the upper limit of normal (ULN), totalbilirubin <2.0×ULN.
Renal function: serum creatinine <1.5×ULN.
Exclusion
Exclusion Criteria:
Patients with recurrent and distant metastasis of nasopharyngeal carcinoma.
The pathology was keratinized squamous cell carcinoma (WHO type I).
Received systemic or local glucocorticoid therapy within 4 weeks prior toenrollment.
Participants who had participated in other drug clinical trials within 3 monthsbefore treatment.
Patients with a known history of allogeneic organ transplantation or allogeneichematopoietic stem cell transplantation;
Patients with idiopathic pulmonary fibrosis, drug-induced pneumonia, institutionalpneumonia (i.e., bronchiolitis obliterans), radiation pneumonia with clinicalsymptoms or requiring steroid treatment, active pneumonia, or other moderate tosevere lung diseases that seriously affect lung function
Have a comorbiditis that requires long-term treatment with immunosuppressive drugsor systemic or local use of immunosuppressive doses of corticosteroids.
Prior use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, oranti-CTLA-4 antibodies (or any other antibody that acts on the T-cell co-stimulationor checkpoint pathway), and efficacy was assessed as progressive at enrollment.
The subject has any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis,hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; Patients withvitiligo or who had complete remission of asthma in childhood and did not requireany intervention as adults were included; Patients with asthma requiring medicalintervention with bronchodilators were not included).
Positive HBV DNA copy number was detected in HIV-positive patients and HBsAgpositive patients (quantitative detection ≥ 1000cps/ml); Chronic hepatitis C bloodscreening positive (HCV antibody positive) with HCV RNA positive detection.
Received any anti-infection vaccine (such as influenza vaccine, chickenpox vaccine,etc.) within 4 weeks before enrollment.
Pregnancy test positive women of childbearing age and breastfeeding women.
Patients who are unable to cooperate with regular follow-up due to psychological,social, family and geographical reasons.
Study Design
Study Description
Connect with a study center
Sun yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

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