Acupuncture for Enhancing the Effect of Immunotherapy in Advanced NSCLC: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Progression free survival
研究概览
简要总结
This multicentre, randomized controlled trial evaluates the effect and safety of integrating acupuncture with immunotherapeutic sensitization in treating NSCLC. Participants will be randomly assigned to undergo either acupuncture or sham acupuncture concurrent with the initial four cycles of standard ICIs combined with chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a histologically-confirmed or cytologically confirmed diagnosis of stage IIIB or IV NSCLC.
- •PD-L1 TPS<50%
- •EGFR/ALK wild-type
- •Has not received prior systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.
- •Has a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- •Age≥18 years
- •Has a life expectancy of at least 3 months
- •Has measurable disease
- •Has adequate organ function
- •Voluntarily enrolled into the study, sign the informed consent form and have good compliance
排除标准
- •Unable to complete baseline assessments
- •Expected to receive radiotherapy within the next 4 cycles
- •With a combination of serious primary diseases of the heart, cerebrovascular, hepatic, renal, and hematopoietic systems
- •With dementia, neurological disorders, mental retardation, or language impairment, and pregnant or breastfeeding women
- •Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs
- •Combined with a primary tumor from other sites
- •Had participated in any other clinical trial within the prior 3 months
- •Has known history of Human Immunodeficiency Virus (HIV) or solid organ transplantation
- •With legal incapacity
- •With skin breakdown at the acupuncture point that interferes with treatment
- •With a pacemaker
- •With a fear of acupuncture
- •Had received acupuncture treatment within 6 weeks
- •Has known active Hepatitis B
- •Has interstitial lung disease or a history of pneumonitis that required oral of IV glucocorticoids to assist with management
- •Has fever (>38°C) or clinically significant infection within 1 week prior to enrolment
- •Has active tuberculosis or indications of severe or uncontrolled systemic diseases
- •With a bleeding tendency, and receiving thrombolytics or anticoagulants
研究组 & 干预措施
Acupuncture
Acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy)
干预措施: acupuncture (Procedure)
Sham acupuncture
Sham acupuncture for 4 times every 3 weeks (one cycle of ICIs combined with chemotherapy) for 12 weeks (4 cycles of ICIs combined with chemotherapy)
干预措施: Sham acupuncture (Procedure)
结局指标
主要结局
Progression free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause
次要结局
- Disease control rate(Through study completion, an average of 3 years.)
- Overall survival(From date of randomization until the date of death from any cause, assessed up to 5 years.)
- Objective response rate(Through study completion, an average of 3 years.)
- Duration of response(Through study completion, an average of 3 years.)
- Symptom evaluation(At the baseline, day 8 of Cycle 1-4 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.)
- Quality of life evaluation(At the baseline, day 8 of Cycle 1-4 (each cycle is 21 days), and day 1 of Cycle 5 (each cycle is 21 days), up to approximately 6 months.)