Phase II multicenter investigator-initiated clinical trial to evaluate safety and efficacy of combination therapy with GEN0101 and standard chemotherapy in patients suffering from pleural mesothelioma.

ational Hospital Organization Osaka Toneyama Medical Center, Director of a hospital, Meinoshin Okumura0 个研究点目标入组 50 人开始时间: 2019年2月5日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients providing a written informed consent by voluntary agreement.
•2) Age 20 =< years old at the time of informed consent
•3) Have a diagnosis of malignant pleural mesothelioma as confirmed by histology
•4) Malignant pleural mesothelioma which is untreated and unresectable
•5) PaO2 >=70 mmHg and SpO2>=93%
•6) Expected survival period is more than 12 weeks after planned start date of investigational product
•7) ECOG Performance Status 0 or 1
•8) Patients with lesions which can be detected by diagnostic imaging such as MRI or CT scan prior to treatment
•9) Meet the defined lab value criteria

•1) Positive result of the prick test of GEN0101
•2) Have serious complications such as uncontrolled active infection
•3) Received systemic chemotherapy, radiotherapy or immunotherapy
•4) Had a history of othr malignancy, except for the relapse-free and metastasis-free for more than 5 years after the last treatment at the registration
•5) Have a interstitial pneumonia or fibrosing disease of the lung that need treatment
•6) Receiving systemic adrenal cortical hormone or immunosuppressive agents
•7) Had a history of the autologous or homogeneous organ or tissue transplantation (Receiving immunosuppressive medication)
•8) PT(%) less than 10% of the lower limit of normal or APTT more than 1.5 times of the upper limit of normal of local reference range at the screening visit
•9) Inappropriate to be enrolled in this study judged by the investigators

发起方

ational Hospital Organization Osaka Toneyama Medical Center, Director of a hospital, Meinoshin Okumura