JPRN-jRCT2033190086招募中1 期
A phase 1/2 clinical trial of a recombinant herpes simplex type 1 with IL-12 expression in patients with malignant melanoma
Okuyama Ryuhei0 个研究点目标入组 24 人开始时间: 2019年8月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histologically confirmed malignant melanoma with stage 3 or 4.
- •2) Patients who have at least one metastatic skin lesion with 10 mm or larger (the longest diameter), and/or at least one metastatic lymph node with 15 mm or larger (the shortest axis).
- •3) Patients who were administered with anti-PD-1 antibody and/or molecular targeted drugs.
- •4) The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI).
- •5) Age >=20 years
- •6) More than 30 days have passed from the previous treatment.
- •7) Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-2.
- •8) Patients without severe disorders (severe myelosuppression, liver dysfunction, chronic renal dysfunction).
- •1) Histologically confirmed malignant melanoma with stage 3 or 4.
- •2) Patients who have at least one metastatic skin lesion with 10 mm or larger (the longest diameter), and/ or at least one metastatic lymph node with 15 mm or larger (the shortest axis).
- •3) Patients who have not been administered with anti-PD-1 antibody or molecular targeted drugs.
- •4) The size and distribution of all the metastatic lesions are recognized with clinical findings including imaging studies (CT, MRI).
- •5) Age >=20 years.
- •6)More than 30 days have passed from the previous treatment.
- •7) Eastern Cooperative Oncology Group (ECOG) performance Status (PS) of 0-1.
- •8) Patients without severe disorders (severe myelosuppression, liver dysfunction, chronic renal dysfunction).
排除标准
- •(Phase 1 and 2)
- •1) Patients who have brain and/or spinal cord metastases.
- •2)Estimated survival period < 6 months.
- •3) Patients who are prgnant or nursing.
- •4) Patients who cannot prevent pregnancy until 6 months after the trial.
- •5) Patients who have severe pleural or pericardial effusion or ascites that requires immediate medical attention.
- •6) Patients who have active infection.
- •7) Patients who have other malignancies.
- •8) Patients who are HIV seropositive or had been HIV seropositve before .
- •9) Patients who have active herpes infection.
- •10) Patients who have allergy to anti-HSV drugs.
- •11) Patients who take >10mg of prednisolone or immunosuppressants.
- •12) Patients who were administered with other clinical trial drugs within 30 days of T-hIL12 administration.
- •13) Patients who had oncolytic virus therapy before.
- •14) Patients who are in conditions considered inadequate for the subject to be enrolled in this study.
研究者
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