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

NCT06591078 | Not Yet Recruiting DMC

• 1 other identifier: HLCMMHPP2023089-08
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer

Keywords

Acupuncture; immunotherapy

Outcome Measures

Primary Outcomes (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.

  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)

• progression free survival

  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.

• overall survival

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

• disease control rate

  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.

• Tumor marker

  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.

• Quality of life improvement

  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.

Study Arms (2)

experimental group

EXPERIMENTAL

1.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.

Other: electropuncture

control group

NO INTERVENTION

1.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.

Interventions

electropuncture OTHER

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.

experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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);
• (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.

Sponsors & Collaborators

• Ying Zhang: lead
• Peking Union Medical College Hospital: collaborator
• Beijing Obstetrics and Gynecology Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• Shanghai University of Traditional Chinese Medicine: collaborator
• Hunan Cancer Hospital: collaborator
• Chongqing University Cancer Hospital: collaborator

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ying Zhang, phd

  Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

yan Wang, phd

CONTACT

18435227044; wangyan1wyw@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share