Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840341
Status:
RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-04-09
Brief Title:
Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Clinical Efficacy of QingyiHuaji Optimized Formula Combined With Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer a Prospective Multicenter Randomized Controlled Clinical Study
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our study is a prospective multicenter randomized controlled clinical study included patients with stage IV pancreatic ductal adenocarcinoma receiving gemcitabine-based first-line combination therapy according to the 2022 NCCN guidelines and with an estimated survival of 3 months According to reports and previous research results we plan to include 306 subjects and the subjects will divide into experimental group and the control group by a ratio of 11 All patients in the treatment group will receive QingyiHuaji optimized formula and standard treatment and patients in the control group will receive placebo combined with standard treatment Overall survival OS is defined as the primary endpoint and progression-free survival DFS quality of life of cancer patients and relief rate of TCM symptoms are considered as the secondary endpoint to observe the clinical efficacy of Qingyihuaji optimized formula combined with standard chemotherapy for stage IV pancreatic ductal adenocarcinoma It will provide high-level evidence-based medical basis for the clinical effect of Qingyihuayi optimization prescription on pancreatic cancer with damp-heat accumulation syndrome The hypothesis of this study is that the combination of Qingyihuaji optimized prescription with standard chemotherapy has the advantage of significantly prolonging the overall survival time and is feasible and safe for the subjects diagnosed with stage IV pancreatic ductal adenocarcinoma by cytology or histology The study lasted for 32 months from 2023 April to December 2025
Detailed Description:
Pancreatic cancer is a digestive tract tumor with high malignancy and poor prognosis The overall 5-year survival rate of early stage patients after surgery is less than 9 while the median survival time of advanced stage patients is only 3-6 months According to statistics in 2020 there were about 420000 new cases of pancreatic cancer worldwide and about 410000 deaths In China with the improvement of peoples living standards and the progress of population aging the incidence of pancreatic cancer is rising year by year ranking 7th among men and the mortality rate is 6th among men and 8th among women
Due to its deep anatomical location lack of typical clinical symptoms and easy invasion and metastasis of tumors pancreatic cancer is difficult to be detected in the early stage More than 80 of patients are in local advanced stage or have distant metastasis at the time of diagnosis thus losing the opportunity for radical surgery Currently gemcitabine combined with albumin-binding paclitaxel regimen or FOLFIRINOX fluorouracil calcium leucovorin irinotecan oxaliplatin regimen is the first-line chemotherapy regimen for pancreatic cancer
However pancreatic cancer has poor sensitivity to chemical and radiotherapy and there has been little progress in targeted therapy and immunotherapy resulting in no significant improvement in the survival rate of pancreatic cancer in recent decades Meanwhile the curative effect of other common tumors has made rapid progress It is estimated by the NCI in the United States that if there is no breakthrough in the treatment of pancreatic cancer pancreatic cancer will become the second largest tumor killer in human by 2030
After nearly 20 years of dedicated research the research team of Fudan University Shanghai cancer center has carried out the integrated treatment mode of traditional Chinese and Western medicine to improve the survival of advanced pancreatic cancer patients making the median OS of advanced pancreatic cancer patients reach the world leading level by 45 longer than that of chemotherapy alone and the 3-year 5-year survival rate reaches 15 and 62 respectively However for patients with locally advanced unresectable pancreatic cancer without metastasis how to improve their survival rate and quality of life is worth further researching
The results suggest that QingyiHuayi formula has certain anti-tumor effect in advanced pancreatic cancer and the combination of Qingyi Huayi formula with chemotherapy can prolong the survival period of patients improve the clinical benefit rate and may improve the therapeutic effective rate without increasing the adverse reaction of radiotherapy and chemotherapy The pathogenesis theory of cancer toxins puts forward that the pathogenesis of cancer toxins should be the core of syndrome differentiation which solves the complicated and difficult problem of TCM tumor classification by disease differentiation Four key points of clinical identification of cancer toxins pathogenesis were put forward to achieve the breakthrough of cancer virus identification and diagnosis technology bottleneck To establish anti-cancer and detoxification treatment methods and classification of anti-cancer and detoxification Chinese medicines and promote the clinical precision treatment and drug use of TCM tumors Therefore Qingyihuayi formula is a safe and effective treatment plan for advanced pancreatic cancer After optimization more clinical studies are needed to clarify the value of Qingyihuayi formula in the treatment of advanced pancreatic cancer and find more target groups of benefits
In order to control random allocation and allocation hiding and ensure the science and standardization of randomized controlled trials IWRS system of Beijing Biaoji Information Technology Co Ltd was used for randomization
In order to ensure data multi-channel upload safe storage data desensitization and data sharing as well as the accuracy of data entry and simple cleaning the EDC system needs to be established Beijing Biaozhi Information Technology Co Ltd is entrusted with the EDC system It includes ①EDC system ②System supporting services CRF annotation eCRF establishment and testing logic verification logic verification plan logic verification rule programming logic verification rule testing EDC training services ③ Project management
The median survival time of locally advanced pancreatic cancer is 443 months reported in relevant literatures and the expected median survival time of the study group is 703 months The test level α is set as 005 the test efficacy 1-β as 080 and the expected shedding rate is 10 After calculating by PASS software a total of 306 patients are expected to be enrolled and the experimental group and control group were randomly divided by 11 with 153 patients in the experimental group and 153 in the control group
Descriptive statistical analysis will be used in this study The measurement data are described by mean standard deviation median lower quartile upper quartile minimum and maximum Count data and rank data list frequency component ratio and rate Describe the number of subjects enrolled in each group and the number of cases dropped and eliminated The final analysis of the study will be based on data collected by the subjects throughout the study period
Due to its deep anatomical location lack of typical clinical symptoms and easy invasion and metastasis of tumors pancreatic cancer is difficult to be detected in the early stage More than 80 of patients are in local advanced stage or have distant metastasis at the time of diagnosis thus losing the opportunity for radical surgery Currently gemcitabine combined with albumin-binding paclitaxel regimen or FOLFIRINOX fluorouracil calcium leucovorin irinotecan oxaliplatin regimen is the first-line chemotherapy regimen for pancreatic cancer
However pancreatic cancer has poor sensitivity to chemical and radiotherapy and there has been little progress in targeted therapy and immunotherapy resulting in no significant improvement in the survival rate of pancreatic cancer in recent decades Meanwhile the curative effect of other common tumors has made rapid progress It is estimated by the NCI in the United States that if there is no breakthrough in the treatment of pancreatic cancer pancreatic cancer will become the second largest tumor killer in human by 2030
After nearly 20 years of dedicated research the research team of Fudan University Shanghai cancer center has carried out the integrated treatment mode of traditional Chinese and Western medicine to improve the survival of advanced pancreatic cancer patients making the median OS of advanced pancreatic cancer patients reach the world leading level by 45 longer than that of chemotherapy alone and the 3-year 5-year survival rate reaches 15 and 62 respectively However for patients with locally advanced unresectable pancreatic cancer without metastasis how to improve their survival rate and quality of life is worth further researching
The results suggest that QingyiHuayi formula has certain anti-tumor effect in advanced pancreatic cancer and the combination of Qingyi Huayi formula with chemotherapy can prolong the survival period of patients improve the clinical benefit rate and may improve the therapeutic effective rate without increasing the adverse reaction of radiotherapy and chemotherapy The pathogenesis theory of cancer toxins puts forward that the pathogenesis of cancer toxins should be the core of syndrome differentiation which solves the complicated and difficult problem of TCM tumor classification by disease differentiation Four key points of clinical identification of cancer toxins pathogenesis were put forward to achieve the breakthrough of cancer virus identification and diagnosis technology bottleneck To establish anti-cancer and detoxification treatment methods and classification of anti-cancer and detoxification Chinese medicines and promote the clinical precision treatment and drug use of TCM tumors Therefore Qingyihuayi formula is a safe and effective treatment plan for advanced pancreatic cancer After optimization more clinical studies are needed to clarify the value of Qingyihuayi formula in the treatment of advanced pancreatic cancer and find more target groups of benefits
In order to control random allocation and allocation hiding and ensure the science and standardization of randomized controlled trials IWRS system of Beijing Biaoji Information Technology Co Ltd was used for randomization
In order to ensure data multi-channel upload safe storage data desensitization and data sharing as well as the accuracy of data entry and simple cleaning the EDC system needs to be established Beijing Biaozhi Information Technology Co Ltd is entrusted with the EDC system It includes ①EDC system ②System supporting services CRF annotation eCRF establishment and testing logic verification logic verification plan logic verification rule programming logic verification rule testing EDC training services ③ Project management
The median survival time of locally advanced pancreatic cancer is 443 months reported in relevant literatures and the expected median survival time of the study group is 703 months The test level α is set as 005 the test efficacy 1-β as 080 and the expected shedding rate is 10 After calculating by PASS software a total of 306 patients are expected to be enrolled and the experimental group and control group were randomly divided by 11 with 153 patients in the experimental group and 153 in the control group
Descriptive statistical analysis will be used in this study The measurement data are described by mean standard deviation median lower quartile upper quartile minimum and maximum Count data and rank data list frequency component ratio and rate Describe the number of subjects enrolled in each group and the number of cases dropped and eliminated The final analysis of the study will be based on data collected by the subjects throughout the study period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None