Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591078
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-05
Brief Title:
Evaluation of Clinical Efficacy of Acupuncture in Improving Immune Response in Patients With Cervical Cancer
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In a prospective multicenter randomized controlled study patients with metastatic recurrent or persistent cervical cancer who were ineligible for surgery andor radiotherapy were randomly assigned in a 11 ratio to either an experimental group or a control group The control group was treated with apatinib combined with callizumabcallizumab 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
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 recurrentmetastatic 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 therapyimmunotherapy combined with chemotherapy as stratification factors at each research center The block length was 6 and the allocation ratio was 11
3 Control methods
This trial included a control group and an experimental group The intervention measures of the experimental group included acupuncture immunotherapy targeted therapyacupuncture immunotherapy chemotherapy The intervention measures of the control group were immunotherapy targeted therapyimmunotherapy 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
This was a prospective multicenter randomized controlled clinical study
2 Random method
This study used central randomization method A total of 90 patients with recurrentmetastatic 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 therapyimmunotherapy combined with chemotherapy as stratification factors at each research center The block length was 6 and the allocation ratio was 11
3 Control methods
This trial included a control group and an experimental group The intervention measures of the experimental group included acupuncture immunotherapy targeted therapyacupuncture immunotherapy chemotherapy The intervention measures of the control group were immunotherapy targeted therapyimmunotherapy 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None