JPRN-jRCTs051180157已完成2 期
A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer. - JGOG1079
TAKESHIMA Nobuhiro0 个研究点目标入组 73 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
研究概览
简要总结
The median PFS (progression-free survival) was greater than 6.2 months and the tumor endpoint was achieved. Adverse events were acceptable and efficacy and safety were achieved.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
- •2.More than 20 years old
- •3.ECOG Performance Status: 0-2
- •4.Life expectancy of >= 90 days
- •5.Histologically confirmed cervical cancer by histopathologic examination of uterine cervix
- •6.Patients with a diagnosis of confirmed cervical cancer such as squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
- •7.Patients can be included if they have measurable diseases.
- •8.Adequate following organ function.
排除标准
- •1.Patient who has received any cheotherapy except for CCRT
- •2.Patients with a history of anti-VEGF and anti-VEGFR treatment
- •3.Patients with multiple cancers whose disease-free period is less than 5 years
- •4.Patient with perforation of the digestive tract and severe fistula within 6 months before registration
- •5.Patients with bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
- •6.Patients who have a high possibility of bleeding due to congenital hemorrhage or other factors
- •7.Patient suspected or diagnosed as arterial thromboembolism (cerebral infarction, myocardial infarction, etc.) at registration
- •8.Patients with metastases to the central nervous system
- •9. Patient with uncontrolled hypertension at registration 10,11,12 Patient with a history of hypersensitivity to the drug used in platinum preparations, combination to bevacizumab and Against drugs or other recombinant humanized antibodies derived from Chinese hamster ovary cells
- •13. Patients for whom invasive surgery has been or may be performed
- •14. Patients who are pregnant or nursing, patients who have a positive pregnancy test
- •15.Patients who have clinical symptoms or findings of intestinal obstruction and need instillation or central venous nutrition
- •16.CTCAE ver.4.03 Patients with a complication of peripheral neuropathy of Grade 3 or more
- •17.CTCAE ver. 4.03 Patients who have a merger of 2 or more Grade 2 blood clots or a history of less than 1 month prior to registration
- •18.Patient with active infection at registration
- •19.Patients who are positive for HIV antibody, HBs antigen, HCV antibody
- •20.Patient who is judged inappropriate to participate in this study by the attending physician
研究者
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