Status:
NOT_YET_RECRUITING
Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy
Lead Sponsor:
Qinghai Red Cross Hospital
Conditions:
Cancer
Adverse Events
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study aims to investigate the preventive effects of electroacupuncture on immune-related adverse events (irAEs) in patients with malignant solid tumors at the neoadjuvant stage, locally advanced,...
Detailed Description
This study is a prospective, multicenter, open-label, single-arm clinical trial aimed at collecting data from patients with malignant solid tumors at the neoadjuvant stage, locally advanced, unresecta...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, any gender, any nationality.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- A definitive diagnosis of malignant tumor confirmed by pathology, and no previous treatment with PD-1/PD-L1 inhibitors.
- Patients who are receiving their first treatment with PD-1/PD-L1 inhibitors monotherapy, PD-1/PD-L1 inhibitors combined with anti-angiogenic agents, or combined chemotherapy.
- Expected survival of more than 3 months.
- Normal bone marrow and organ function.
- Premenopausal women must use adequate contraception.
- Written informed consent obtained from the patient prior to enrollment.
Exclusion
- Patients who have previously received or are currently receiving immunotherapy monotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with targeted therapy.
- Patients who have undergone acupuncture, radiotherapy, or surgery within 4 weeks prior to the start of treatment.
- Patients who have received any dose of systemic corticosteroid treatment within 72 hours prior to Day 1 of Cycle 1.
- Patients with active systemic autoimmune diseases within the past 2 years (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with a history of vitiligo or asthma in childhood who have been in complete remission with no intervention in adulthood may be included; subjects requiring bronchodilator medical intervention should be excluded), diagnosed with immunodeficiency or treated with immunosuppressive therapy within the past week, human immunodeficiency virus (HIV) (+), history of non-infectious pneumonia treated with glucocorticoids, pneumonia, active tuberculosis, active hepatitis B or C virus infection, or currently undergoing any systemic treatment for active infections.
- Significant abnormal laboratory values (platelet count, absolute neutrophil count, free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone(TSH), adrenocorticotropic hormone (ACTH), morning cortisol, glycated hemoglobin (HbA1c), C-peptide, autoantibodies, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, prothrombin time/international normalized ratio (PT/INR), serum bilirubin, amylase, lipase, CRP).
- Skin diseases or inflammatory skin reactions that may interfere with clinical trial outcomes.
- Patients who have developed lymphedema at the site of acupuncture stimulation after receiving any acupuncture treatment.
- Patients who fear electroacupuncture stimulation or are allergic to stainless steel needles.
- Patients with psychiatric disorders, or those taking any antipsychotic or antidepressant medications.
- Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss.
- Patients with diabetes.
- Any other diseases, metabolic disorders, physical examination results, or clinical laboratory findings that raise reasonable suspicion of a disease or condition that may affect the interpretation of the outcomes or put the participant at high risk for treatment complications.
- Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
- Severe medical or psychiatric conditions.
- Any patient deemed unsuitable for enrollment by the investigator.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT06891521
Start Date
March 20 2025
End Date
June 1 2028
Last Update
March 24 2025
Active Locations (1)
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1
Qinghai, China, Qinghai Red Cross Hospital
Xining, Qinghai, China, 810000