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2023-05-01
2025-12-30
2025-12-30
306
NCT05840341
Fudan University
Fudan University
INTERVENTIONAL
Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer
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 1:1. 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.
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 420,000 new cases of pancreatic cancer worldwide, and about 410,000 deaths. In China, with the improvement of people's 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 6.2%, 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 4.43 months reported in relevant literatures, and the expected median survival time of the study group is 7.03 months. The test level (α) is set as 0.05, the test efficacy (1-β) as 0.80, 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 1:1, 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-04-09 | N/A | 2023-04-22 |
2023-04-22 | N/A | 2023-05-03 |
2023-05-03 | N/A | 2023-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Experimental group QingyiHuaji optimized formula combined with standard treatment | DRUG: QingyiHuaji optimized formula
|
| PLACEBO_COMPARATOR: Placebo group placebo combined with standard treatment | DRUG: QingyiHuaji optimized formula
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival (OS) | defined as the time from randomization to death from any cause. Subjects who are still alive at the time of final analysis or who have been lost to follow-up will be truncated at the last date of known survival. | From date of randomization until the date of death from any cause, assess up to 24 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Disease Free Survival | defined as the time from randomization to radiographic tumor progression or death from any cause. Subjects with no evidence of progress at the time of final analysis or who have been lost to follow-up will be truncated at the date of the last tumor evaluation. | From date of randomization until the date of first documented progression, assessed up to 24 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Hao Chen, professor Phone Number: 18017312356 Email: chengkll@sina.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
