试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Male or female patients over the age of 18 at the time of signing the Test Subject Agreement; However, in Korea, female patients over the age of 19
- •2. Histologically identified, excisible local progression, HPV positive (positively identified in p16 immunohistochemistry and positive in HPV-16 and/or HPV-18 nucleic acid tests) patients in LA HNSCC
- •3. Patients who have never received any other chemo before
- •4. Eastern Cognitive Oncology Group (ECOG) Activity Status 0-1
- •5. Patients with life expectancy of at least 6 months
- •6. Patients who have agreed to provide archival tumor tissue specimens or fresh biopsy specimens for analysis of baseline biomarker tissue, including PD-L1 staining, during biopsies or surgery. If the patient does not have archival tissue and does not have tumor lesions that can be sampled from biopsies or surgeries, it will be excluded from the trial.
- •7. It should be a patient with appropriate organ function as defined in Table 1 below. Samples must be collected within 28 days of the commencement of clinical trials.
- •Table 1. Requirements for long-term functions for conformity assessment
- •Physical relation laboratory test value
- •Absolute neutropenic number (ANC) set 1,500/µL
- •Platelet deposition 100, 000/µL
- •Hemoglobin test 9.0 g/dL or test 5.6 mmol/L1
- •For creatinine or creatine cleaning rate measurement or computational value 2 (GFR can be used instead of creatinine or CrCl, 1.5 × ULN, or creatinine> 1.5x test institute ULN, the test subject is 1930 mL/min
- •Total Bilubin + 1.5 × ULN, or Total Bilubin Concentration> 1.5 xULN. Direct Bilubin (3ULN and ALT [3ULN)
- •AST (SGOT) and ALT (SGPT) × ULN (55 × ULN, for test subjects with liver metastasis)
- •Blood clotting
- •As long as the international standardized ratio (INR) or protrombin time (PT), activation tromboplastin time (aPTT), 1.5 × ULN, PT or aPTT is within the treatment scope of the intended anticoagulant use
- •ALT (SGPT) = alanine aminoosferase; AST (SGOT) = amino aminosferase; serum polymerase (GFR); ULN = upper limit of the upper limit.
- •1 You must meet the standard with no dependence on red blood cells and receiving a concentrated red blood cell (packed red blood cell, pRBC) transfusion within the past four weeks.
- •2 Creatine cleaning rate (CrCl) should be calculated using the Corkroft-Gault formula.
- •Note: This table summarizes the lab figures for suitability-definition required for treatment. These laboratory numerical requirements must be modified in accordance with local regulations and guidelines for specific chemotherapy.
- •8. Patients with RECIST measurable diseases defined below:
- •A tumor lesion with lymph node detection 1.5 cm in phase reduction of long-axis diameter (LD) 1 cm or CT (restoration interval 1.5mm) in axis CT or MRI imaging (restoration interval 1.5mm)
- •9. In case of fertile women (WOCBP), the result of serum or urine pregnancy test conducted within 72 hours of the first administration of clinical trials is negative. If the urine test results are positive or can not be confirmed negative, a serum pregnancy test should be performed.
- •10. Infertile women must agree to go through the whole process and to use appropriate dual contraception by 120 days after the last administration of the clinical medication. Women who are menopause (over the age of 45 and have no menstruation for more than a year) and women who are surgically infertile are exempt from this requirement.
- •Note: Abstinence is allowed if it
排除标准
- •Exclusion Criteria:
- •1. Where it is non-resected metastatic or recurrent cancer
- •2. There are other malignant diseases that are currently in progress or require active treatment within the past three years
- •In case it is confirmed.
- •See also: Skin basal cell carcinoma, skin flat cell carcinoma, or
- •Test subjects with in-site cancer (e.g. breast cancer) are not excluded.
- •3. Patients who are expected to require other forms of antiviral treatment during testing
- •There's a whole range of chemotherapy, radiation therapy, biological therapy, or immunotherapy that's not specified in the plan
- •I'm included.
- •4. Patients with a history of active central nervous system (CNS) metastasis and/or cancer meningitis
- •A patient with controlled CNS metastasis
- •5. Treatment using anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or other stimuli in the past
- •Or drugs that act directly on co-suppressive T-cell receptors (e.g. CTLA-4, OX40, CD137)
- •A patient who was treated by me
- •6. Whole body immunosuppressive therapy within the past two years (e.g. disease control, cortisol, or
- •Patients with active autoimmune diseases that require the use of immunosuppressants).
- •Alternative therapies (e.g. thyroxine, insulin, or physiological dysfunction caused by adrenal or pituitary dysfunction)
- •Cortisol replacement therapy) is acceptable because it is not considered a form of systemic treatment.
- •7. A patient who received a solid organ transplant from the same family or a bone marrow transplant from the same family
- •8. B-PD-1/PD-L1/PD-L2, anti-cancer monoclone antibodies (mAb) within 4 weeks of the first administration of clinical trials.
- •Bebasizumab, Cetuxizumab, etc.) injected before or after 4 weeks
- •Drug adverse reactions have not yet recovered (e.g., below Grade 1 or at the baseline level)
- •9. Within four weeks of the first administration of this clinical trial, the entire body, including other clinical trials, will receive chemotherapy
- •A patient who received targeted low molecular therapy with a half-life of less than 48 hours within two weeks
- •FYI: The test subjects must have a grade 1 or lower adverse reaction due to previous treatment
- •Neurodysphoria under Grade 2 and/or below Grade 2 should have been restored to the baseline level
- •Anemia can be appropriate.
- •Note: If the subject of the test has undergone major surgery, the subject must be subject to the examination before the commencement of treatment
- •It must be properly recovered from toxicity and/or complications caused by arbitration.
- •10. Patients who have received radiation treatment within two weeks before the commencement of clinical trials. All subjects are subject to the test
- •It must have been recovered from radiation-related toxicity.
- •11. Blood products (including platelets and red blood cells) were transfused within four weeks of the first administration of clinical trials
- •I have been given G-CSF, GM-CSF or recombinant red blood cell generators (including G-CSF)
- •The patient I have
- •Bilateralness that cannot be mitigated by urethral stent or percutaneous kidney leakage surgery
- •A patient with hydronephrosis
- •13. Severe (grade 3) overreaction to one of the additive components of pembrolizumab and/or pembrolizumab
- •The patient I have
- •14. There is a history of (uncommunicable) epileptic pneumonia that requires steroids, or currently has epileptic pneumonia
- •The patient I have
- •15. Patients diagnosed with immunization or long-term systemic steroids (10 milligrams of frednisone per day)
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