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Cervical CancerNCT06591078

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

A study testing electropuncture in people with Cervical Cancer, run by Ying Zhang.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
electropuncture
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
15 Sep 2024to 1 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
  • Age 18-70 years old;
  • 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.
  • The ECOG score is 0 or 1;
  • Life expectancy exceeds 3 months;
  • The patient's important organs function normally, as follows:
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  • 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;
  • Thyroid stimulating hormone (TSH) level ≤1×ULN; Note: Patients with free triiodothyronine [FT3] or free thyroxine [FT4] levels ≤1× ULN may be included.
  • Patients can sign written informed consent.

Who cannot join

  • histopathological diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or tumors other than adenocarcinoma;
  • have participated in another clinical trial, or completed another clinical trial within 4 weeks;
  • previous use of immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies;
  • a known history of allergy to any component of carrilizumab preparations or other monoclonal antibodies;
  • 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.
  • 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.
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  • 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);
  • 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);
  • 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.
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

yan Wang, phd contact

18435227044

wangyan1wyw@163.com

About this study

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

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.

Read the 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

Conditions
Cervical Cancer
Being tested
electropuncture
Keywords
Acupuncture; immunotherapy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electropunctureOther

    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.

Study groups in NCT06591078
Study groupRoleWhat they receive
experimental groupExperimental1.Carrilizumab for injection; 200mg; Q14d; 2.Apatinib; 250mg Qd or Bid or chemotherapy; 3.electropuncture; 4/Q28d. Use up to 2 years/ patient disease progression(about 1 year)/ unacceptable toxic effects, use of prohibited therapies (such as antitumor therapy other than chemotherapy and beva or non-palliative radiotherapy)/ investigator's decision to discontinue the regimen/ or patient's withdrawal of consent treatment may be discontinued. If a patient with a confirmed complete response has received at least eight cycles of immunotherapy, including at least two cycles beyond a complete response, treatment will be discontinued.
Receives: Other: electropuncture
control groupNo intervention1.Carrilizumab for injection; 200mg; Q14d; 2.Apatinib; 250mg Qd or Bid or chemotherapy; Use up to 2 years/ patient disease progression(about 1 year)/ unacceptable toxic effects, use of prohibited therapies (such as antitumor therapy other than chemotherapy and beva or non-palliative radiotherapy)/ investigator's decision to discontinue the regimen/ or patient's withdrawal of consent treatment may be discontinued. If a patient with a confirmed complete response has received at least eight cycles of immunotherapy, including at least two cycles beyond a complete response, treatment will be discontinued.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective remission rate

    ORR refers to the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time required. Cases with complete response (CR) and partial response (PR) were included.

    Measured: 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 (7)

  1. progression free survival

    ORR refers to the proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time required. Cases with complete response (CR) and partial response (PR) were included.

    Measured: 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.

  2. overall survival

    From randomization to the time of death from any cause.

    Measured: The patients were followed up until death or at least 2 years

  3. disease control rate

    DCR refers to the proportion of patients whose tumor volume has shrunk or stabilized to a predetermined value and can maintain the minimum time required. Cases with complete response (CR), partial response (PR), and stable disease (SD) were included

    Measured: 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.

  4. Tumor marker

    Tumor marker level of CA 125 and SCC.

    Measured: 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.

  5. Quality of life improvement

    Use scale to evaluated the quality of life of patients.

    Measured: 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.

  6. Adverse events associated with immunotherapy and targeted therapy and their severity

    NCI CTCAE V5.0 evaluation criteria for adverse events, including but not limited to skin reactions, pneumonia, colitis, nephritis, endocrine diseases, etc

    Measured: 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.

  7. Security Index

    Blood, urine, stool routine, liver function (ALT, AST), kidney function (Cr, BUN) examination.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start15 Sep 2024 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06591078
Sponsor's protocol ID
HLCMMHPP2023089-08
Status last verified
Sep 2024
First submitted
5 Jun 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang Y, Xie Y, Fang Y, Sui B, Yuan X, Chen Y, Zhang Y. Acupuncture combined with immunotherapy for recurrent and metastatic cervical cancer: a pilot RCT protocol. Front Oncol. 2026 Jan 28;16:1718170. doi: 10.3389/fonc.2026.1718170. eCollection 2026.

    PubMed 41684588

Questions about this trial

What is this clinical trial studying?

A study testing electropuncture in people with Cervical Cancer, run by Ying Zhang.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact yan Wang, phd (18435227044, wangyan1wyw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective remission rate (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06591078, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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