Trial Title:
Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer
NCT ID:
NCT05840341
Condition:
Pancreatic Neoplasms
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Pancreatic Neoplasms
Traditional Chinese Medicine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
QingyiHuaji optimized formula
Description:
Qingyihuaji Optimization Formula each bag contains: (1)Scutellaria barbata D. Don
(Banzhilian); (2) Hedyotis diffusa Willd. (Sheshecao); (3) Amorphophallus rivieri Durieu
(Sheliugu); (4) Amomi Fructus Rotundus (Doukou); (5) Gynostemma pentaphyllum (Thunb.)
Makino (Jiaogulan); (6) Semen Coicis (Yiyiren); (7) Ganoderma lucidum (Curtis) P. Karst.
(Lingzhi). One bag at a time, twice a day, rinsing with boiling water, continuous
administration, oral administration in the morning and evening, every 3 weeks as a cycle.
Arm group label:
Experimental group
Arm group label:
Placebo group
Other name:
standard chemotherapy
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 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.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed Stage IV pancreatic ductal adenocarcinoma.
2. The expected survival time is >3 months;
3. Patients meet the standard treatment of gemcitabine - based first-line combination
therapy recommended by the 2022 edition of the NCCN Pancreatic Cancer Guidelines;
4. Age above 18 years old and ≤75 years old;
5. ECOG physical state score 0-1;
6. Patients own adequate organ and bone marrow function, defined as neutrophils
≥1,500/ul, hemoglobin ≥ 8.0gm /dL, platelets ≥80,000/uL, serum creatinine < 2.0
mg/dL, bilirubin < 1.5 mg/dL, alanine aminotransferase < 3 times the upper limit of
normal; If obstructive jaundice was allowed to enter the study after desicrin
treatment, liver function markers were moderately relaxed to bilirubin < 2.5 mg/dL
and alanine aminotransferase < 5 times the upper limit of normal.
7. Patients must have measurable lesions that meet the RECIST1.1 evaluation criteria.
Bone scan abnormalities alone or osteolytic changes shown on plain radiographs
cannot be measurable lesions, but can be evaluated in conjunction with bone scan
abnormalities. Simple osteogenic bone metastases, pleural or peritoneal exudation,
and radiation injury could not be considered as measurable lesions.
8. Patients who have not received "Qingyi Huayji Optimized formula " before (patients
who have taken medicine for less than 2 weeks can be included at the discretion of
the researchers) and who have received other traditional Chinese medicine treatment
before must stop taking medicine 1 week before this study.
9. Female subjects of reproductive age must undergo a negative pregnancy test within 2
weeks prior to study drug initiation and be willing to use a medically approved
highly effective contraceptive (e.g., intrauterine device, contraceptive or condom)
during the study period and within 3 months after the last study drug
administration; Male subjects with partners of women of reproductive age should
agree to use effective contraceptive methods during the study period and within 3
months after the last study administration;
10. Patients is expected to possess good compliance, can understand and sign written
informed consent, and willing to cooperate with the collection of TCM syndrome
information;
11. SIRI value ≥0.8; SIRI = N × M/L, N, M, and L represent peripheral blood neutrophil,
monocyte, and lymphocyte counts, respectively.
Exclusion Criteria:
1. Patients with ECOG score ≥2, who could not tolerate any antitumor therapy, or who
could only receive the best supportive treatment were not considered for inclusion
in this study.
2. The expected survival time < 3 months.
3. Other serious diseases or conditions, including deep vein thrombosis of the lower
extremities, congestive heart failure (New York Heart Association Grade III or IV),
unstable angina, etc.
4. Patients with co-infection requiring intravenous antibiotic treatment.
5. Pregnant or lactating women. Women of childbearing age who were unwilling or unable
to use an acceptable method of contraception throughout the treatment period of this
trial and within 12 weeks after the final administration of the study drug.
6. Known pancreatic neuroendocrine tumors, acinar cell carcinoma, intraductal papillary
tumors and other types of pancreatic tumors.
7. Past or concurrent cancers with a primary focus or histologically distinct from
pancreatic cancer, except cervical carcinoma in situ, treated basal cell carcinoma,
and superficial bladder tumors (Ta, Tis & T1). Any cancer that had been cured for
more than 3 years prior to inclusion was admitted.
8. Those who are known to be allergic to components of Qingyihuaji optimized formula.
9. Unable to swallow Traditional Chinese medicine or untreated malabsorption syndrome,
or unwilling to take Traditional Chinese medicine.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lixing Liu
Phone:
13401009117
Email:
liulixing1986@126.com
Facility:
Name:
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ye Zhang
Phone:
18262636620
Email:
zhangye881221@163.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hao Chen
Phone:
18017312356
Email:
chengkll@sina.com
Investigator:
Last name:
Linjia Peng
Email:
Sub-Investigator
Investigator:
Last name:
Yujie Li
Email:
Sub-Investigator
Investigator:
Last name:
Hao Chen
Email:
Principal Investigator
Investigator:
Last name:
Jiangang Zhao
Email:
Sub-Investigator
Facility:
Name:
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aiguang Zhao
Phone:
13661472241
Email:
2538312201@qq.com
Start date:
May 1, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840341
