Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study
- Conditions
- Non-small Cell Lung CancerNon-Small-Cell Lung Carcinoma
- Interventions
- Procedure: acupunctureProcedure: Sham acupuncture
- Registration Number
- NCT06461338
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acupuncture 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) Sham acupuncture 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)
- Primary Outcome Measures
Name Time Method Progression free survival 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
- Secondary Outcome Measures
Name Time Method Overall survival From date of randomization until the date of death from any cause, assessed up to 5 years. Overall survival is defined as the time until death due to any cause
Objective response rate Through study completion, an average of 3 years. Objective response rate is defined as the proportion of patients achieving complete (iCR/CR) or partial (iPR/PR) response according to iRECIST or RECIST V.1.1 criteria
Disease control rate Through study completion, an average of 3 years. Disease control rate is determined by the percentage of patients who achieve CR, PR, or SD as defined by iRECIST or RECIST V.1.1 criteria. This encompasses all instances of CR, PR, and SD (CR + PR + SD).
Duration of response Through study completion, an average of 3 years. Duration of response is assessed only in patients achieving CR, PR, or nPR and was defined as the time from first assessment showing CR, PR, or nPR to earliest date of either PD or death.
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. According to the requirements of Lung cancer symptom scale (LCSS), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 0 and 10. The higher score indicates the worse symptom.
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. According to the requirements of European Organisation for Research and Treatment of Cancer-quality of life core questionnaire (EORTC QLQ-C30)/Lung cancer 13 items (LC13), the scoring results of each field of the scale were recorded in CRF. The score of this questionnaire ranges between 1 and 4. The higher score indicates the worse quality of life.
Trial Locations
- Locations (3)
The First Affiliated Hospital of Guangzhou University of Chinese Medicine.
🇨🇳Guangzhou, Guangdong, China
Jiangsu Provincial Hospital of Chinese Medicine
🇨🇳Nanjing, Jiangsu, China
Guangdong Provincial Hospital of Chinese Medicine
🇨🇳Guangzhou, Guangdong, China