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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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.
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