JPRN-UMIN000031508已完成未知
Combination of checkpoint inhibitor and radiotherapy for recurrent gastric cancer after initial treatment with standard therapy. - CIRCUIT
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 41
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) No tumor lesions to be irradiated. 2) History of other cancers (intraepithelial cancer of uterine cervix, fully treated basal cell carcinoma of skin, malignant tumors treated before >=5 yrs and w/o recurrence are excluded). 3) Past severe hypersensitive reaction to antibody (Ab) drugs. 4) Use of immunosuppressant drugs or adrenocortical hormone (predonine or prednisolone (PDN/PSL) equivalent >=15 mg/day). 5) Active autoimmune diseases or history of recurrent autoimmune diseases. Patients (Pts) with type-1 diabetes, hypothyroid controlled with hormone replacement therapy, dermatosis without need for systemic therapy (for example, vitiligo, psoriasis, alopecia) are eligible. 6) History of interstitial pneumonia or pulmonary fibrosis diagnosed with imaging studies (CT is preferred) or clinical findings. 7) Presence of severe disease or pathology. 8) Pts during pregnancy or lactation. 9) Fertile female pts w/o intention to practice contraception. 10) Fertile male pts w/o intention to practice contraception during and for 7 months after the study, if the partners are fertile females. 11) Prohibited pre-treatment. Within 56 days before entry: radioactive drugs (exclude those intended for testing or diagnosis) Within 28 days before entry: systemic adrenocortical hormone (excludes temporary use or PDN/PSL equivalent of <15 mg/day), immunosuppressant drugs, anti-cancer drugs, adhesive treatment of pleura or pericardium, surgery with general anesthesia, use of unapproved drugs. Within 14 days before entry: surgery with local or superficial anesthesia. 12) Concurrent participation in other clinical trials/studies (excludes those w/o intervention). 13) Positivity in HIV-1 Ab test, HIV-2 Ab test, or HTLV-1 Ab test. 14) History of treatment using ONO-4538, anti-PD-1 Ab, anti-PD-L1 Ab, anti-PD-L2 Ab, anti-CD137 Ab, anti-CTLA-4 Ab, or other Ab or drugs intended for T-cell regulation. 15) Pts whom the physicians in the study consider inappropriate for entry.
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