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Electroacupuncture for Preventing Adverse Events of Cancer Immunotherapy Phase 2 123 Immunotherapy Preventive

Not yet recruiting
Clinical Trial NCT06891521 is designed to study Prevention for Cancer, Adverse Events. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 20 March 2025 until the study accrues 123 participants. Led by Qinghai Red Cross Hospital, this study is expected to complete by 1 June 2028. The latest data from ClinicalTrials.gov was last updated on 24 March 2025.
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, 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,...Show More
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, unresectable, or metastatic stages, who are receiving immune checkpoint inhibitors (ICIs) monotherapy, ICIs combined with anti-angiogenic agents, or ICIs combined with chemotherapy. The objective is to evaluate the efficacy and s...Show More
Official Title

Electroacupuncture for Preventing Adverse Events Associated With Cancer Immunotherapy: A Prospective, Multicenter, Open-Label, Single-Arm Clinical Study

Conditions
CancerAdverse Events
Other Study IDs
  • QRCH-2025002
NCT ID Number
NCT06891521
Start Date (Actual)
2025-03-20
Last Update Posted
2025-03-24
Completion Date (Estimated)
2028-06-01
Enrollment (Estimated)
123
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Electroacupuncture
immunotherapy
immune-related adverse events (irAEs)
malignant tumors
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalElectroacupuncture group
Patients received electroacupuncture therapy on the day before and the first day of each ICIs treatment cycle. Intervention: The patient received electroacupuncture and standard antitumor therapy.
Electroacupuncture
Patients 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 sing...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
48 weeks.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
48 weeks.
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.
48 weeks.
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.
48 weeks.
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.
48 weeks.
The incidence of any grade and Grade ≥3 treatment-related adverse events (TRAEs) associated with ICIs combined with chemotherapy.
TRAEs are defined as any adverse events caused by ICIs combined with chemotherapy during or after the treatment period. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
48 weeks.
The incidence of any grade and Grade ≥3 immune-related adverse events (irAEs) associated with ICIs monotherapy.
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.
48 weeks.
The incidence of any grade and Grade ≥3 treatment-related adverse events (TRAEs) associated with ICIs combined with anti-angiogenic agents.
TRAEs are defined as any adverse events caused by ICIs combined with anti-angiogenic agents during or after the treatment period. Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
48 weeks.
The incidence of any grade and Grade ≥3 hyperthyroidism and hypothyroidism.
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
48 weeks.
The incidence of any grade and Grade ≥3 rash.
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
48 weeks.
The incidence of any grade and Grade ≥3 hepatitis.
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
48 weeks.
The incidence of any grade and Grade ≥3 pneumonia.
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
48 weeks.
The incidence of any grade and Grade ≥3 abnormal blood glucose levels.
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
48 weeks.
Comparison of biomarker changes before and after electroacupuncture treatment.
The differences in biomarkers will be monitored through hematological parameters, including: inflammatory biomarkers such as C-reactive protein (CRP), procalcitonin (PCT), inflammatory cytokines like IL-1β, IL-6, IL-10, TNF-α, IFN-γ, and changes in the proportions of peripheral blood lymphocyte subsets (CD4+, CD8+ T cells, natural killer cells (NK cells), regulatory T cells (Treg cells), and myeloid-derived suppressor cells (MDSCs)), as well as tumor markers.
48 weeks.
The incidence of adverse events related to electroacupuncture treatment.
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 to determine the proportion of side effects associated with electroacupuncture.
48 weeks.
The evaluation of the difference in quality of life before and after electroacupuncture treatment.
Quality of life will be assessed using the EuroQol Five-Dimensional Questionnaire (EQ-5D-5L). EQ-5D-5L is a standardized tool for assessing health-related quality of life, which includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels describing an individual's functional or well-being status in a specific area. Additionally, the EQ-5D-5L includes a visual analogue scale, allowing individuals to rate their overall health status on a scale from 0 (worst health) to 100 (best health).
48 weeks.
16.Adherence to electroacupuncture treatment.
48 weeks.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age ≥ 18 years, any gender, any nationality.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  3. A definitive diagnosis of malignant tumor confirmed by pathology, and no previous treatment with PD-1/PD-L1 inhibitors.
  4. 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.
  5. Expected survival of more than 3 months.
  6. Normal bone marrow and organ function.
  7. Premenopausal women must use adequate contraception.
  8. Written informed consent obtained from the patient prior to enrollment.

  1. Patients who have previously received or are currently receiving immunotherapy monotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with targeted therapy.
  2. Patients who have undergone acupuncture, radiotherapy, or surgery within 4 weeks prior to the start of treatment.
  3. Patients who have received any dose of systemic corticosteroid treatment within 72 hours prior to Day 1 of Cycle 1.
  4. 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.
  5. 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).
  6. Skin diseases or inflammatory skin reactions that may interfere with clinical trial outcomes.
  7. Patients who have developed lymphedema at the site of acupuncture stimulation after receiving any acupuncture treatment.
  8. Patients who fear electroacupuncture stimulation or are allergic to stainless steel needles.
  9. Patients with psychiatric disorders, or those taking any antipsychotic or antidepressant medications.
  10. Any unresolved skin toxicity caused by previous chemotherapy or radiotherapy, except for hair loss.
  11. Patients with diabetes.
  12. 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.
  13. Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
  14. Severe medical or psychiatric conditions.
  15. Any patient deemed unsuitable for enrollment by the investigator.
Qinghai Red Cross Hospital logoQinghai Red Cross Hospital
Study Central Contact
Contact: QiuXia Dong, Dr., +86 0971-8267613, [email protected]
1 Study Locations in 1 Countries

Qinghai

Qinghai, China, Qinghai Red Cross Hospital, Xining, Qinghai, 810000, China
Qiu Xia Dong, Dr., Contact, +86 0971-8267613, [email protected]