Nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:sintilimab(200mg,Q3W)+gemcitabine(1000mg/m2,D18,Q3W)+cisplatin(80mg/m2,D1),3 cycles
IMPT(6996cGy/33F)+gemcitabine(1000mg/m2,D18,Q3W)+cisplatin(40mg/m2,D1,8,15),2 cycles
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any experimental procedures; 2. Gender is not limited, age range is 18-70 years old; 3. As determined by histology or cytology, the researcher assessed it as stage III-IVA (excluding T3-4N0 and T3N1) locally advanced nasopharyngeal carcinoma without any treatment; 4. ECOG PS score is 0-1; According to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), there should be at least one measurable lesion on imaging; 6. Expected survival time >= 3 months; 7. Adequate organ function, subjects must meet the following laboratory indicators: 1) In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) was >= 1.5x10^9/L. 2) Platelets >= 100 × 10^9/L without blood transfusion in the past 14 days. 3) Hemoglobin >=9 g/dL (90 g/L) or >= 5.6 mmol/L in the past 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin 1.5 × ULN but direct bilirubin = 60 ml/min; 7) Good coagulation function: International normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or partial thromboplastin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) <= 1.5 times ULN; Or the subject is receiving anticoagulant therapy, but the prothrombin time (PT) or activated partial thromboplastin time (PTT) is within the therapeutic range of the intended use of the anticoagulant; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 9) The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included); 8. For female subjects of childbearing age, a urine or serum pregnancy test with negative results should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy; 9. If there is a risk of conception, all subjects (male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with other malignant tumors other than locally advanced nasopharyngeal carcinoma within 5 years before the first administration and who have not been cured (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ that has undergone radical resection); 2. Currently participating in interventional clinical research treatment, or having received other research drugs or used research instruments for treatment within 4 weeks before the first administration; 3. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137); 4. History of radiation therapy or chemotherapy in the past 5. Have received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect (including thymosin, interferon and interleukin) within 2 weeks before the first administration; Within 2 years prior to the first administration, there has been an active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants). Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments; 7. Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy; Note: Physiological doses of glucocorticoids (<= 10 mg/day of prednisone or equivalent) are allowed to be used; 8. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Individuals who are known to be allergic to the active ingredients or excipients of the investigational drug Xindilimumab, as well as the chemotherapy drugs used in this study; 10. Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., = grade 1 or baseline, excluding fatigue or hair loss); 11. Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the group: 1) Before the first administration, the HBV viral load was less than 1000 copies/ml (200 IU/ml), and subjects should receive anti HBV treatment throughout the entire study drug treatment period to avoid viral reactivation 2) For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary 13. Active HCV infected subjects (HCV antibody positive and HCV-RNA level above the detection limit); 14. Administer a live vaccine within 30 days prior to the first dose (Day 1 of the first cycle); Note: It is allowed to receive inactivated vaccine for seasonal influenza within 30 days before the first administration; However, intranasal administration of attenuated live influenza vaccin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3y-overall survival rate;3y-disease-free-survival rate;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactJin Gao
Anhui Provincial Cancer Hospital
Outcome results
None listed