NCT07188857尚未招募不适用
Study on the Relationship Between Opioid Drugs and the Therapeutic Efficacy of Immunotherapy
Hubei Cancer Hospital0 个研究点目标入组 100 人开始时间: 2025年9月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- The relationship between different degrees of pain control and the therapeutic efficacy of ICIs (immune checkpoint inhibitors) in patients with advanced cancer pain.
研究概览
简要总结
Relationship between pain and the efficacy of immunotherapy: Does the degree of pain control affect the therapeutic efficacy of ICIs? Does the use of opioid drugs independently affect the efficacy of immunotherapy?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years; Histologically confirmed advanced NSCLC (Stage IIIb-IV); Need to receive ICIs treatment; Accompanied by moderate or severe pain (NRS score ≥ 4); Need to use opioid drugs for pain management; Able to understand and sign the informed consent form.
排除标准
- •Suffering from severe dysfunction of important organs such as heart, liver, and kidney; Suffering from mental illness or receiving treatment with psychotropic drugs; Pregnant or lactating women; Participating in other clinical trials; Allergic to opioid drugs.
结局指标
主要结局
The relationship between different degrees of pain control and the therapeutic efficacy of ICIs (immune checkpoint inhibitors) in patients with advanced cancer pain.
时间窗: From enrollment to the end of treatment at 8 weeks
The therapeutic efficacy includes progression-free survival (PFS), objective response rate (ORR), and overall survival (OS). Additionally, analyze whether the use of opioid drugs independently affects the therapeutic efficacy.
次要结局
未报告次要终点
研究者
Yu Qian
Doctor
Hubei Cancer Hospital
相似试验
撤回
4 期
Intraoperative Methadone for Postoperative Pain ControlBariatric Surgery CandidateNCT05845359Montefiore Medical Center
已完成
不适用
Efficiency of Botulinum Toxin type-a in the Management of the Myofascial PainMyofascial Pain - Dysfunction Syndrome of TMJNCT06840730Hacettepe University25
已完成
不适用
Comparison of Patient Controlled & Continuous Epidural Analgesia in Thoraco-abdominal Surgeries in Cancer PatientsPainNCT02803385Tata Memorial Centre70
已完成
不适用
Comparing the pain relief effect of two types of pain killers in patients of hernia surgeryCTRI/2016/08/007217Government Medical College and Hospital120
已完成
不适用
Opioid Taper StudyChronic PainNCT03912298University of Pennsylvania7