Clinical trial NCT06591078: Evaluation of Clinical Efficacy of Acupuncture in Improving Immune Response in Patients With Cervical Cancer
Official title: Clinical Efficacy Evaluation and Mechanism Study of Potential Advantageous Diseases of Acupuncture - Evaluation of Clinical Efficacy of Acupuncture in Improving Immune Response in Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Acupuncture; immunotherapy
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Beijing Obstetrics and Gynecology Hospital
name: Peking University Cancer Hospital & Institute
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Sichuan Cancer Hospital and Research Institute
name: Shanghai University of Traditional Chinese Medicine
name: Hunan Cancer Hospital
name: Chongqing University Cancer Hospital
First posted: 2024-09-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Primary outcomes:
measure: objective remission rate
timeFrame: The patients were evaluated every 8 weeks ±2 weeks from the beginning of treatment until 40 weeks, and then every 12 weeks ±2 weeks until the end of treatment.
Secondary outcomes:
measure: progression free survival
timeFrame: The patients were evaluated every 8 weeks ±2 weeks from the beginning of treatment until 40 weeks, and then every 12 weeks ±2 weeks until the end of treatment.
measure: overall survival
timeFrame: The patients were followed up until death or at least 2 years
measure: disease control rate
timeFrame: The patients were evaluated every 8 weeks ±2 weeks from the beginning of treatment until 40 weeks, and then every 12 weeks ±2 weeks until the end of treatment.
measure: Tumor marker
timeFrame: The patients were evaluated every 8 weeks ±2 weeks from the beginning of treatment until 40 weeks, and then every 12 weeks ±2 weeks until the end of treatment.
measure: Quality of life improvement
timeFrame: The patients were evaluated every 8 weeks ±2 weeks from the beginning of treatment until 40 weeks, and then every 12 weeks ±2 weeks until the end of treatment.
measure: Adverse events associated with immunotherapy and targeted therapy and their severity
timeFrame: The patients were evaluated every 8 weeks ±2 weeks from the beginning of treatment until 40 weeks, and then every 12 weeks ±2 weeks until the end of treatment.
measure: Security Index
timeFrame: he patients were evaluated every 8 weeks ±2 weeks from the beginning of treatment until 40 weeks, and then every 12 weeks ±2 weeks until the end of treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
name: Ying Zhang, phd
role: STUDY_DIRECTOR
References: