Nasopharyngeal carcinoma
Conditions
Interventions
Experiment group:High and low dose radiotherapy combined with Toripalimab
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 - 75 years, both sexes; 2. Histologically confirmed moderately differentiated or undifferentiated metastatic nasopharyngeal carcinoma (WHO staging types II-III); 3. Prior failure of at least first-line platinum-containing chemotherapy regimen, with or without immunotherapy; (Definition of treatment failure: progression during or after chemotherapy treatment after metastasis; progression within 6 months after concurrent radiotherapy can be counted as first-line treatment. All changes in treatment regimen due to drug intolerance are not considered a treatment failure.) 4. Have at least two measurable lesions (other than brain metastases) that meet the high-dose radiotherapy (HDRT) and low-dose radiotherapy (LDRT) radiation requirements according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1). 5. ECOG:0~2 score; 6. Expected survival of at least >= 12 weeks; 7. Functioning of vital organs in accordance with the following requirements (no blood components, cell growth factors, leukostimulants, platelet-raising drugs, anemia-correcting drugs are allowed within 14 days prior to the first administration of the investigational drug): (1) absolute neutrophil count (ANC) >= 1.5×10^9/L; (2) Platelets >= 100×10^9/L; (3) hemoglobin >= 9 g/dL; (4) Serum albumin >=2.8g/dL; (5) total bilirubin 60 mL/min. 8. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5 x ULN (screening is possible for use of stable doses of anticoagulant therapy such as low molecular heparin or warfarin and INR within the expected therapeutic range of anticoagulants); 9. Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant, and cooperated with follow-up; 10. The investigator believes that there is a benefit to be gained.
Exclusion criteria
Exclusion criteria: 1. Evidence of interstitial lung disease or active, non-infectious pneumonia; 2. Subjects undergoing coronary artery bypass surgery; 3. Subjects with inadequate cardiac, hepatic and renal function; 4. Subjects with severe uncontrolled psychiatric symptoms; 5. Subjects whose imaging shows that the tumor has invaded a vital vessel or who, in the judgment of the investigator, have a very high probability of invading a vital vessel during tumor treatment and causing fatal hemorrhage. 6. Treatment with systemic corticosteroids or other systemic immunosuppressive drugs (including, but not limited to, prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-tumor necrosis factor drugs) within 4 weeks prior to enrollment, or where systemic immunosuppressive drugs are expected to be required during the trial. Subjects with active, known or suspected autoimmune diseases such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes requiring only hormone replacement therapy; 7. Known history of allogeneic organ or allogeneic hematopoietic stem cell transplantation.8) Uncontrolled concomitant disease, including but not limited to. (1) Active or poorly controlled serious infection; (2) Human immunodeficiency virus (HIV) infection (HIV antibody positive); (3) Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection; (4) Active tuberculosis; (5) Symptomatic congestive heart failure (New York Heart Association; (6) Uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg); (7) Previous arterial thromboembolic events, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment; (8) Concomitant disease requiring anticoagulation; (9) Uncontrolled hypercalcemia (Ca2+ >1.5 mmol/L or Ca >12 mg/dl or corrected serum calcium >ULN), or symptomatic hypercalcemia during bisphosphonate therapy. 9) Other primary malignancies, with the following exceptions: (radical non-melanoma skin cancer or cured cervical carcinoma in situ;); (10) Subjects with other diseases or abnormal laboratory findings that, in the judgment of the investigator, may increase the risk of enrollment and treatment or interfere with the interpretation of study results and may be excluded; (11) Pregnant or lactating women; (12) Those deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival time;Overall survival;Disease control rate;Duration of remission;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactLei Zeng
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed