Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQinghai Red Cross Hospital
About this trial
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, unresectable, or metastatic stages, who are receiving immune checkpoint inhibitors (ICIs) monotherapy, ICIs combined with anti-angiogenic agents, or ICIs combined with chemotherapy. The study will evaluate the efficacy, safety and mechanisms of electroacupuncture in preventing irAEs in a multicenter setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Electroacupuncture
Procedure/SurgeryPatients received electroacupuncture on the day before and the first day of each ICIs treatment cycle. The electroacupuncture points selected Zusanli (ST36), Quchi (LI11), and Hegu (LI4). Patients will be positioned supine, and the acupuncturist will disinfect the local skin at the acupuncture points using 75% ethanol on cotton balls. A disposable acupuncture needle (0.3mm × 40mm) will be inserted using either a single-hand or double-hand needling technique, with rapid, direct insertion. Once the needle reaches a depth of approximately 0.5 cun, the technique of lifting, thrusting, twirling, and rotating will be applied. After obtaining "de qi", the needles will be retained for 30 minutes. Needling will be performed once every 10 minutes, and the needling technique used will be a balanced reinforcing and reducing method. Electroacupuncture will be applied using a dense-wave form, with a frequency of 2 Hz and an intensity not exceeding 10 mA.
Treatment groups
123 Participants
are divided into 1 treatment groupGroup A: Electroacupuncture groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The overall incidence of any grade of immune-related adverse events (irAEs).
IrAEs are defined as any adverse events potentially related to immune mechanisms that occur during or after ICIs treatment. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
48 weeks.Secondary outcomes
1
The incidence of Grade ≥3 immune-related adverse events (irAEs).
IrAEs are defined as any adverse events potentially related to immune mechanisms that occur during or after ICIs treatment. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
48 weeks.2
The time to onset of Grade ≥3 immune-related adverse events (irAEs).
The time to onset is defined as the period from the initiation of immune checkpoint inhibitor (ICIs) treatment to the occurrence of the immune-related adverse event. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
48 weeks.3
The time to onset of any grade of immune-related adverse events (irAEs).
The time to onset is defined as the period from the initiation of immune checkpoint inhibitor (ICIs) treatment to the occurrence of the immune-related adverse event. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
48 weeks.4
The incidence of any grade and Grade ≥3 immune-related adverse events (irAEs) associated with ICIs combination therapy.
IrAEs are defined as any adverse events potentially related to immune mechanisms that occur during or after ICIs treatment. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
48 weeks.Sponsors and contacts
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Source ClinicalTrials.gov
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