jRCT1041250152招募中不适用
A multicenter prospective study to explore safety and efficacy of drug therapy for recurrent cervical cancer with prior platinum chemotherapy
未提供0 个研究点目标入组 300 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Female
入选标准
- •Recurrent cervical cancer with a history of plati num-based systemic chemotherapy (cisplatin used in CCRT is not included in systemic chemotherapy).
- •Previously administered platinum-based systemic chemotherapy must be one line. Postoperative adjuvant chemotherapy is one line, and a history of immune checkpoint inhibitors is not required.
- •The histological subtype is epithelial malignant tumor.
- •Age 18 years or older at the time of registration.
- •Performance status (PS) is 0 or 1 according to ECOG criteria.
- •Patients with measurable lesions.
- •No brain metastasis or meningeal metastasis accompanied by central nervous system symptoms.
- •None of the following I to IV regarding the period since previous treatment apply.
- •I. If prior chemoradiotherapy was administered, the last radiation was exposed within 42 days.
- •II. If radiation therapy (including palliative radiation therapy) was administered as prior treatment, it must be less than 14 days since the last radiation therapy.
- •III. If prior surgery has been performed, it must be less than 28 days since the surgery.
- •IV. If chemotherapy was administered as prior treatment, it must be less than 21 days since the last chemotherapy treatment.
- •The most recent test results within 14 days prior to registration (the same day of the week two weeks prior to the registration date is acceptable) must meet all of the following criteria:
- •I. Neutrophil count >= 1,500/mm3
- •II. Hemoglobin >= 9 g/dl (Allow transfusion before blood collection)
- •III. Platelet count >= 100,000/mm3
- •IV. Total bilirubin =< 1.5 mg/dL
- •V. AST =< 100 U/L
- •VI. ALT =< 100 U/L
- •VII. Serum creatinine =< 1.5 mg/dL or creatinine clearance >= 50 mL/min (Cockcroft-Gault)
- •VIII. SpO2 >= 95 %
- •IX. ECG: Normal or changes not requiring treatment
- •Written consent to participate in the study has been obtained from the patient.
排除标准
- •Active double cancers (synchronous double cancers/multiple cancers and metachronous double cancers/multiple cancers with a disease-free interval of less than two years that require treatment).
- •Infection requiring systemic treatment.
- •Have a fever of 38.0 degrees Celsius or higher at the time of registration.
- •Are pregnant, possibly pregnant, within 28 days of giving birth, or breastfeeding.
- •Patients who have psychiatric disorders or symptoms that interfere with daily life and are judged to have difficulty participating in the study.
- •A history of severe drug hypersensitivity.
- •Paclitaxel, carboplatin, and cisplatin are contraindicated.
- •Receiving systemic (oral or intravenous) administration of steroids or other immunosuppressants.
- •Have diabetes mellitus treated with continuous insulin use or uncontrolled diabetes mellitus.
- •Have uncontrolled hypertension.
- •Patients with unstable angina (angina that has developed or worsened within the past three weeks) or a history of myocardial infarction within the past six months.
- •Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- •Symptomatic central nervous system metastases (brain or spinal cord).
- •HBs antigen positive, HCV antibody positive and HCV-RNA positive (HCV-RNA measurement is performed if HCV antibody is positive), HIV antibody positive (HIV antibody measurement before enrollment is not required, but if it is positive, you will be ineligible).
- •Interstitial pneumonia, pulmonary fibrosis, or severe emphysema, or multiple conditions as diagnosed by chest CT.
- •Have a history of hypersensitivity to preparations containing polysorbate 80, polyoxyethylene castor oil (Cremophor EL) (e.g., cyclosporine), or hydrogenated castor oil (e.g., injectable vitamins).
- •Alcohol intolerance.
- •Those deemed inappropriate by the facility's principal investigator.
研究者
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