Evaluation of Clinical Efficacy of Acupuncture in Improving Immune Response in Patients With Cervical Cancer

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.