Trial Title:
Evaluation of Clinical Efficacy of Acupuncture in Improving Immune Response in Patients With Cervical Cancer
NCT ID:
NCT06591078
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
Acupuncture; immunotherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
electropuncture
Description:
The needle was retained for 30 minutes. During the retention period, the needle was
lifted and twisted for 3 times with even small amplitude every 10 minutes, and the
complement method was performed for 3 times. No manipulation before the needle, cotton
ball press directly out of the needle.
④ Frequency, course and time: Start at the same time as immunotherapy, and complete 1-2
times of electroacupuncture treatment per week; Electroacupuncture was performed 4 times
per 28 days. The number of electroacupuncture treatment cycles and the number of
immunotherapy courses should be consistent.
Arm group label:
experimental group
Summary:
In a prospective, multicenter, randomized, controlled study, patients with metastatic,
recurrent, or persistent cervical cancer who were ineligible for surgery and/or
radiotherapy were randomly assigned in a 1:1 ratio to either an experimental group or a
control group." The control group was treated with apatinib combined with
callizumab/callizumab combined with chemotherapy, and the experimental group was treated
with electroacupuncture on the basis of the treatment. Anti-tumor efficacy, immune
function efficacy, quality of life and safety were used as the outcome indicators.
Detailed description:
1. Study Design Types:
This was a prospective, multicenter, randomized controlled clinical study.
2. Random method:
This study used central randomization method. A total of 90 patients with
recurrent/metastatic cervical cancer were enrolled and divided into 8 research
centers. Patients were divided into control group (group A) and experimental group
(group B) according to the pathological type, PD-L1 expression level, immunotherapy
combined with targeted therapy/immunotherapy combined with chemotherapy as
stratification factors at each research center. The block length was 6, and the
allocation ratio was 1∶1.
3. Control methods:
This trial included a control group and an experimental group. The intervention
measures of the experimental group included acupuncture + immunotherapy + targeted
therapy/acupuncture + immunotherapy + chemotherapy. The intervention measures of the
control group were immunotherapy + targeted therapy/immunotherapy + chemotherapy.
4. Sample size calculation:
This study intends to conduct preliminary exploratory research and use small samples for
clinical observation. The sample size of each group of exploratory research should be
more than 30 according to literature. This exploratory study intends to include 90
patients to be allocated to the experimental group and the control group
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with metastatic, recurrent or persistent cervical cancer including squamous
cell carcinoma, adenosquamous cell carcinoma, that is not suitable for surgery
and/or radiation therapy;
2. Age 18-70 years old;
3. Have at least one measurable lesion according to RECIST 1.1; Note: Measurable
lesions are defined as those that can be accurately measured in at least one
dimension (the longest diameter recorded by computed tomography (CT) scanning,
magnetic resonance imaging (MRI) is ≥10mm; Lymph nodes must be ≥15mm on the short
axis. Tumors within the previously irradiated area will be designated as
"off-target" lesions unless progress is recorded at least 90 days after completion
of radiation therapy or a biopsy is performed to confirm persistence.
4. The ECOG score is 0 or 1;
5. Life expectancy exceeds 3 months;
6. The patient's important organs function normally, as follows:
Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelet count ≥80×10^9/L; Hemoglobin
≥90g/L;
④ Total bilirubin ≤1.5× upper limit of normal (ULN);
⑤ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN;
Note: In patients with liver metastasis, AST and ALT levels were ≤5 ×ULN;
⑥ Creatinine ≤1.5×ULN or creatinine clearance ≥60 ml/min (Cockcroft-Gault formula);
⑦ Baseline albumin ≥28g/L;
7. Thyroid stimulating hormone (TSH) level ≤1×ULN; Note: Patients with free
triiodothyronine [FT3] or free thyroxine [FT4] levels ≤1× ULN may be included.
8. Patients can sign written informed consent.
Exclusion Criteria:
1. histopathological diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or
tumors other than adenocarcinoma;
2. have participated in another clinical trial, or completed another clinical trial
within 4 weeks;
3. previous use of immune checkpoint inhibitors, including but not limited to other
anti-PD-1 and anti-PD-L1 antibodies;
4. a known history of allergy to any component of carrilizumab preparations or other
monoclonal antibodies;
5. Immunosuppressive drugs are currently required; Note: Prednisone > 10 mg/d or
equivalent dose is prohibited within 2 weeks prior to administration of the study
drug.
6. Patients with any active autoimmune disease or history of autoimmune disease,
including but not limited to the following: hepatitis, pneumonia, uveitis, colitis
(inflammatory bowel disease), pituitaritis, vasculitis, nephritis, hyperthyroidism
and hypothyroidism, asthma patients requiring intermittent use of bronchodilators or
other medical interventions; Note: Excluding vitiligo, resolved childhood
asthma/atopic subjects.
7. Clinically significant cardiovascular disease, including but not limited to
congestive heart failure (NYHA level > 2), unstable or severe angina, severe acute
myocardial infarction within 1 year prior to enrollment, supraventricular or
ventricular arrhythmias requiring medical intervention, or QT interval ≥470
milliseconds (women);
8. Arterial thrombosis or venous thrombosis occurs within 6 months; Hypertension
medications do not adequately control hypertension (systolic blood pressure ≥140 mm
Hg and/or diastolic blood pressure ≥90 mm Hg);
(10) proteinuria ≥ (++) or 24-hour urinary protein total > 1.0g; (11) Abnormal
coagulation (INR > 2.0, PT > 16s), bleeding tendency or receiving thrombolytic or
anticoagulant therapy; (12) has not recovered from an adverse event (other than hair
loss) from prior administration (i.e. ≤ Grade 1 or baseline); (13) Known active central
nervous system metastases; (14) Patients with prior invasive malignancy and any evidence
of disease within the past 5 years; Note: Exceptions are basal cell carcinoma of the
skin, squamous cell carcinoma of the skin, or cervical cancer in situ that has received
potentially curative treatment.
(15) Have an active infection that requires systemic treatment; (16) A history of
immunodeficiency, including seropositivity for human immunodeficiency virus (HIV) or
other acquired or congenital immunodeficiency diseases; Hepatitis B virus (HBV) > 2000
IU/ml or DNA≥1×10^4/ml; Or hepatitis C virus (HCV) RNA ≥1×10^3/ml); (18) Received live
vaccine within 4 weeks before the first trial treatment; Note: Inactivated virus vaccines
against seasonal influenza are allowed. (19) Patients with suspected intestinal
obstruction or risk of vagino-rectal fistula or vagino-vesical fistula; (20) Any other
medical, mental, or social condition that the investigator believes may interfere with
the subject's rights, safety, welfare, or ability to sign informed consent, cooperate,
and participate in the study, or with the interpretation of the results.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
September 15, 2024
Completion date:
November 1, 2026
Lead sponsor:
Agency:
Ying Zhang
Agency class:
Other
Collaborator:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Beijing Obstetrics and Gynecology Hospital
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Shanghai University of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Chongqing University Cancer Hospital
Agency class:
Other
Source:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06591078
