recurrent/metastatic nasopharyngeal carcinoma
Conditions
Interventions
Test group:EGFR Antibody Combined with Programmed Death 1 (PD-1) Antibody and Chemotherapy
Phase 1: 3+3 dose ramp up:There are three dose groups of Nivolumab (combination therapy with PD-1 inhibitor and GP chemotherapy dose unchanged), which are 300mg, 600mg, and 900mg, respectively
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Nasopharyngeal carcinoma patients with initial metastasis or recurrence/metastasis after radical treatment; 2. Age between 18 to 75 years old. Both men and women are acceptable; 3. pathologically confirmed nasopharyngeal carcinoma; 4. ECOG score: 0 to 1; 5. No previous anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy or biological therapy for recurrence/metastasis have been received; 6. No contraindications for chemotherapy, immunotherapy or targeted therapy; 7. At least one measurable lesion that meets the RECIST 1.1 standard; 8. The standards for blood routine examination should meet the following requirements: WBC >=3.0×10^9/L, ANC >=1.5×10^9/L, PLT >=100×10^9/L, HGB >=90g/L (no blood transfusion or blood products within 14 days, and no correction using G-CSF and other hematopoietic stimulating factors); 9. Biochemical tests should meet the following standards: TBIL =60ml/min (Cockcrot-Gault formula); 10. Good coagulation function: defined as an international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; If the subject is undergoing anticoagulant therapy, it is acceptable as long as the PT is within the prescribed range of anticoagulant drugs; 11. Myocardial enzyme spectrum is within the normal range; 12. Women of childbearing age must have taken reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment with a negative result, and be willing to use effective contraceptive methods during the trial and within 3 months after the last administration of anti-PD-1 antibody. For male subjects whose partners are women of childbearing age, effective contraceptive methods should be used during the trial and within 3 months after the last administration of anti-PD-1 antibody; 13. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up;
Exclusion criteria
Exclusion criteria: 1. Patients with recurrence who can undergo local resection or radiotherapy; 2. Known to be allergic to the research drug or any of its excipients, or to other monoclonal antibodies; 3. Has symptoms of central nervous system metastasis such as cerebral edema and requires hormone intervention; 4. Active infection or an unexplained fever >38.5? during the screening period or before the first administration (as determined by the researchers, the subjects with fever caused by tumors could be enrolled). 5. Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [can be included after hormone replacement therapy is normal]); Patients with vitiligo or those whose childhood asthma has been completely relieved and do not require any intervention in adulthood can be included. However, asthma patients who need medical intervention with bronchodilators cannot be included; 6. Those with congenital or acquired immune deficits (such as HIV-infected individuals), active hepatitis B (HBV-DNA >=10^3 copies /ml), or hepatitis C (hepatitis C antibody positive, and HCR-RNA higher than the detection limit of the analytical method); 7. Previously or concurrently with other uncured malignant tumors, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer; 8. Suffering from uncontrolled cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >=470 ms); According to the NYHA standard, patients with grade III-IV heart failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography; Myocardial infarction occurred within one year; 9. If the subject has undergone major surgery, the toxic reactions and/or complications caused by the surgical intervention must be fully recovered before the start of treatment; 10. Within 4 weeks before the first use of the study drug (for subjects who have entered the follow-up period, the time of the last use of the experimental drug or device is calculated) or currently participating in other clinical studies; 11. Those who have received live vaccines within four weeks prior to the first use of the study drug are allowed to receive inactivated virus vaccines administered by injection for seasonal influenza, but are not allowed to receive attenuated live influenza vaccines administered through the nose; 12. Pregnant or lactating women; 13. After the researchers' judgment, the subjects have other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, having severely abnormal laboratory test values, family or social factors that may affect the subjects' safety or the collection of experimental data;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| one year progression free survival(1y-PFS);Stage I: maximum tolerated dose (if any);Stage I: recommended dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Quality of life (QoL);safety;Overall survival(OS);Disease control rate(DCR); | — |
Countries
China
Contacts
Public ContactZhao Chong
Sun Yat-sen University Cancer Center
Outcome results
None listed