An interventional study of electropuncture in Cervical Cancer, sponsored by Ying Zhang. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Ying Zhang · Not applicable, Interventional, and Treatment
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.
Study Design Types:
This was a prospective, multicenter, randomized controlled clinical study.
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.
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.
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
1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 1,411 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Ying Zhang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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;
Exclusion Criteria:
(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.
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
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.
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.
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.
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.
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.
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.
overall survival
From randomization to the time of death from any cause.
Time frame: The patients were followed up until death or at least 2 years
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
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.
Tumor marker
Tumor marker level of CA 125 and SCC.
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.
Quality of life improvement
Use scale to evaluated the quality of life of patients.
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.
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
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.
Security Index
Blood, urine, stool routine, liver function (ALT, AST), kidney function (Cr, BUN) examination.
Time frame: 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.
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Start is estimated for Sep 2024; primary completion for Nov 2026, 25 months later.
Of 395 non-industry interventional studies with no phase under Uterine Cervical Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 71. This study's planned 25 months is below that.
Counting every sponsor, half of 409 studies reached it within 33 months; a quarter within 15 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Ying Zhang