NCT05640726尚未招募2 期
The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- progression free survival
研究概览
简要总结
To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the rectum；
- •The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis)；
- •ECOG PS 0-2；
- •CHild Pugh A；
- •Estimated survival ≥3 months;
- •Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
- •Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;
- •Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.
排除标准
- •Pregnant or lactating women;
- •No previous antitumor therapy；
- •No previous liver local therapy；
- •No contraception during the reproductive period;
- •patients known to have a history of allergy to any study drug, similar drug or excipient;
- •Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- •Patients with a history of thromboembolism, except those caused by PICC;
- •Patients with active infection;
- •Other conditions that the investigator determines are not suitable for inclusion in the study.
研究组 & 干预措施
(SCRT) followed by PD-1+ standard therapy
Experimental
干预措施: PD-1 (Drug)
(SCRT) followed by PD-1+ standard therapy
Experimental
干预措施: SCRT (Radiation)
(SCRT) followed by PD-1+ standard therapy
Experimental
干预措施: Bevacizumab (Drug)
(SCRT) followed by PD-1+ standard therapy
Experimental
干预措施: Oxaliplatin (Drug)
(SCRT) followed by PD-1+ standard therapy
Experimental
干预措施: Calcium folinate (Drug)
(SCRT) followed by PD-1+ standard therapy
Experimental
干预措施: 5-fluorouracil (Drug)
结局指标
主要结局
progression free survival
时间窗: up to 36 months
The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).
次要结局
- objective response rate(every 3 months (up to 36 months）)
研究者
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Unknown
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