lung cancer
Conditions
Interventions
Acupuncture group:Conventional immunotherapy combined with acupuncture intervention
Sham acupuncture group:Conventional immunotherapy
Sponsors
Shanghai Pulmonary Hospital Affiliated To Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, regardless of sex; 2. Histologically or cytologically confirmed advanced non-squamous non-small cell lung cancer (NSCLC); 3. Clinical stage IIIB/IIIC disease unsuitable for curative treatment, stage IV disease, or recurrent/metastatic NSCLC; 4. Scheduled to receive a standardized PD-1 inhibitor-based combination therapy regimen; 5. At least one measurable lesion according to RECIST version 1.1; 6. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0–1; 7. Estimated life expectancy of >=3 months; 8. Adequate major organ function and ability to tolerate the study treatment and follow-up; 9. Voluntary participation in this study with written informed consent.
Exclusion criteria
Exclusion criteria: 1. Small cell lung cancer or mixed small cell lung cancer; 2. Active autoimmune disease or requiring systemic immunosuppressive therapy; 3. Uncontrolled symptomatic brain metastases or meningeal metastases; 4. Active interstitial lung disease, severe infection, or severe dysfunction of vital organs such as the heart, liver, or kidneys; 5. Pregnant or breastfeeding women; 6. Contraindications to acupuncture, such as skin infection at the acupuncture site, obvious bleeding tendency, or other conditions unsuitable for acupuncture; 7. Mental or cognitive impairment, poor compliance, or inability to cooperate with treatment and follow-up; 8. History of other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, cervical carcinoma in situ, and similar conditions; 9. Previous severe adverse reactions to anti-PD-1 monoclonal antibody therapy, and deemed by the investigator unsuitable for retreatment; 10. Any other condition that, in the investigator’s judgment, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30;Lymphocyte subsets; | — |
Countries
China
Contacts
Public ContactPeng Yanbin
Shanghai Pulmonary Hospital Affiliated To Tongji University
Outcome results
None listed