Pancreatic NeoplasmsPhase 3NCT05840341
Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer
A Phase 3 study testing QingyiHuaji optimized formula in people with Pancreatic Neoplasms, run by Fudan University at 4 sites in China.
Trial summary
This prospective, multicenter, randomized, double-blind, placebo-controlled phase 3 trial included adults with histologically or cytologically confirmed stage IV pancreatic ductal adenocarcinoma who were eligible for gemcitabine-based first-line combination chemotherapy according to the 2022 NCCN guidelines and had an… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- QingyiHuaji optimized formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 4 sitesChina
- Study dates
- 17 Apr 2023to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed Stage IV pancreatic ductal adenocarcinoma.
- The expected survival time is >3 months;
- Patients meet the standard treatment of gemcitabine - based first-line combination therapy recommended by the 2022 edition of the NCCN Pancreatic Cancer Guidelines;
- Age above 18 years old and ≤75 years old;
- ECOG physical state score 0-1;
- 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.
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- 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.
- 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.
- 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;
- 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;
- SIRI value ≥0.8; SIRI = N × M/L, N, M, and L represent peripheral blood neutrophil, monocyte, and lymphocyte counts, respectively.
Who cannot join
- 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.
- The expected survival time < 3 months.
- 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.
- Patients with co-infection requiring intravenous antibiotic treatment.
- 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.
- Known pancreatic neuroendocrine tumors, acinar cell carcinoma, intraductal papillary tumors and other types of pancreatic tumors.
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- 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.
- Those who are known to be allergic to components of Qingyihuaji optimized formula.
- Unable to swallow Traditional Chinese medicine or untreated malabsorption syndrome, or unwilling to take Traditional Chinese medicine.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100000
Affiliated Hospital of Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, 210000
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200000
About this study
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
This prospective, multicenter, randomized, double-blind, placebo-controlled phase 3 trial included adults with histologically or cytologically confirmed stage IV pancreatic ductal adenocarcinoma who were eligible for gemcitabine-based first-line combination chemotherapy according to the 2022 NCCN guidelines and had an estimated survival of more than 3 months.
The planned sample size was 306 participants. A total of 305 participants were enrolled and randomly assigned in a 1:1 ratio to receive either Qingyi Huaji (QYHJ) optimized formula combined with standard treatment or a matched placebo combined with the same standard treatment.
Read more
The primary outcome was overall survival, defined as the time from randomization to death from any cause and assessed for up to 24 months. Secondary outcomes included progression-free survival, quality of life, safety, and improvement in traditional Chinese medicine symptoms. Traditional Chinese medicine syndrome classification was recorded for exploratory analyses but was not an eligibility requirement.
The hypothesis was that adding QYHJ optimized formula to standard chemotherapy would prolong overall survival without causing an unacceptable increase in toxicity. The study was conducted from April 17, 2023, through December 30, 2025.
Read the 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 stage IV pancreatic ductal adenocarcinoma, improving survival and quality of life remains an important clinical need.
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 sample-size calculation assumed a median overall survival of 4.43 months in the control group and 7.03 months in the experimental group. 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.
- Conditions
- Pancreatic Neoplasms
- Being tested
- QingyiHuaji optimized formula, Matched placebo
- Keywords
- Pancreatic Neoplasms, Traditional Chinese Medicine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QingyiHuaji optimized formulaDrug
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.
Matched placeboDrug
The sensory-matched placebo was manufactured to resemble QYHJ optimized formula in appearance, color, taste, odor, packaging, labeling, and administration schedule. Each placebo sachet contained 2% QYHJ granules, 86.13% maltodextrin, 10% lactose, 1.28% caramel pigment, 0.08% lemon-yellow pigment, 0.01% sunset-yellow pigment, and 0.50% bittering agent. Participants took one 8-g sachet orally twice daily, in the morning and evening, after reconstitution with boiling water. Treatment was administered continuously, with each 3-week period defined as one study-product cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | QingyiHuaji optimized formula combined with standard treatment Receives: Drug: QingyiHuaji optimized formula |
| Placebo group | Placebo comparator | placebo combined with standard treatment Receives: Drug: Matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until the date of death from any cause, assess up to 24 months
Secondary outcomes (1)
Progression-Free Survival (PFS)
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.
Measured: From date of randomization until the date of first documented progression, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start17 Apr 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chen, Fudan University
- Investigators
- Hao Chen, Study director, Fudan UniversityLi Feng, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical SciencesJun Qian, Study chair, Affiliated Hospital of Nanjing University of Chinese MedicineAiguang Zhao, Study chair, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840341
- Sponsor's protocol ID
- 2212267-7
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
PubMed 33433946Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Sun D, Cao M, Li H, He S, Chen W. Cancer burden and trends in China: A review and comparison with Japan and South Korea. Chin J Cancer Res. 2020 Apr;32(2):129-139. doi: 10.21147/j.issn.1000-9604.2020.02.01.
PubMed 32410791Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
PubMed 26830752Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
PubMed 21561347Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.
PubMed 21969517Hua YQ, Wang P, Zhu XY, Shen YH, Wang K, Shi WD, Lin JH, Meng ZQ, Chen Z, Chen H. Radiofrequency ablation for hepatic oligometastatic pancreatic cancer: An analysis of safety and efficacy. Pancreatology. 2017 Nov-Dec;17(6):967-973. doi: 10.1016/j.pan.2017.08.072. Epub 2017 Sep 1.
PubMed 29129384Ouyang H, Wang P, Meng Z, Chen Z, Yu E, Jin H, Chang DZ, Liao Z, Cohen L, Liu L. Multimodality treatment of pancreatic cancer with liver metastases using chemotherapy, radiation therapy, and/or Chinese herbal medicine. Pancreas. 2011 Jan;40(1):120-5. doi: 10.1097/MPA.0b013e3181e6e398.
PubMed 20683216
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05840341
- Acronym / sponsor ID
- 2212267-7
- Conditions
- Pancreatic Neoplasms
- Keywords
- Pancreatic Neoplasms, Traditional Chinese Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multicenter, randomized, double-blind, placebo-controlled phase 3 trial included adults with histologically or cytologically confirmed stage IV pancreatic ductal adenocarcinoma who were eligible for gemcitabine-based first-line combination chemotherapy according to the 2022 NCCN guidelines and had an estimated survival of more than 3 months.
The planned sample size was 306 participants. A total of 305 participants were enrolled and randomly assigned in a 1:1 ratio to receive either Qingyi Huaji (QYHJ) optimized formula combined with standard treatment or a matched placebo combined with the same standard treatment.
The primary outcome was overall survival, defined as the time from randomization to death from any cause and assessed for up to 24 months. Secondary outcomes included progression-free survival, quality of life, safety, and improvement in traditional Chinese medicine symptoms. Traditional Chinese medicine syndrome classification was recorded for exploratory analyses but was not an eligibility requirement.
The hypothesis was that adding QYHJ optimized formula to standard chemotherapy would prolong overall survival without causing an unacceptable increase in toxicity. The study was conducted from April 17, 2023, through December 30, 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 stage IV pancreatic ductal adenocarcinoma, improving survival and quality of life remains an important clinical need.
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 sample-size calculation assumed a median overall survival of 4.43 months in the control group and 7.03 months in the experimental group. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: QingyiHuaji optimized formulaQingyiHuaji optimized formula combined with standard treatment |
| Placebo group | Placebo comparator | Drug: Matched placeboplacebo combined with standard treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed Stage IV pancreatic ductal adenocarcinoma.
- The expected survival time is >3 months;
- Patients meet the standard treatment of gemcitabine - based first-line combination therapy recommended by the 2022 edition of the NCCN Pancreatic Cancer Guidelines;
- Age above 18 years old and ≤75 years old;
- ECOG physical state score 0-1;
Key exclusion criteria (9 listed)
- 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.
- The expected survival time < 3 months.
- 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.
- Patients with co-infection requiring intravenous antibiotic treatment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QingyiHuaji optimized formulaQingyihuaji 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. | Drug | Experimental group |
| Matched placeboThe sensory-matched placebo was manufactured to resemble QYHJ optimized formula in appearance, color, taste, odor, packaging, labeling, and administration schedule. Each placebo sachet contained 2% QYHJ granules, 86.13% maltodextrin, 10% lactose, 1.28% caramel pigment, 0.08% lemon-yellow pigment, 0.01% sunset-yellow pigment, and 0.50% bittering agent. Participants took one 8-g sachet orally twice daily, in the morning and evening, after reconstitution with boiling water. Treatment was administered continuously, with each 3-week period defined as one study-product cycle. | Drug | Placebo group |
Primary outcome
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assess up to 24 months
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.
1 secondary outcome
Progression-Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression, assessed up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 33433946Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 32410791Sun D, Cao M, Li H, He S, Chen W. Cancer burden and trends in China: A review and comparison with Japan and South Korea. Chin J Cancer Res. 2020 Apr;32(2):129-139. doi: 10.21147/j.issn.1000-9604.2020.02.01.
- Background: PubMed 26830752Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
- Background: PubMed 21561347Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
- Background: PubMed 21969517Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. doi: 10.1200/JCO.2011.36.5742. Epub 2011 Oct 3.
- Background: PubMed 29129384Hua YQ, Wang P, Zhu XY, Shen YH, Wang K, Shi WD, Lin JH, Meng ZQ, Chen Z, Chen H. Radiofrequency ablation for hepatic oligometastatic pancreatic cancer: An analysis of safety and efficacy. Pancreatology. 2017 Nov-Dec;17(6):967-973. doi: 10.1016/j.pan.2017.08.072. Epub 2017 Sep 1.
- Background: PubMed 20683216Ouyang H, Wang P, Meng Z, Chen Z, Yu E, Jin H, Chang DZ, Liao Z, Cohen L, Liu L. Multimodality treatment of pancreatic cancer with liver metastases using chemotherapy, radiation therapy, and/or Chinese herbal medicine. Pancreas. 2011 Jan;40(1):120-5. doi: 10.1097/MPA.0b013e3181e6e398.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao Chen study director
Fudan University
Li Feng study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jun Qian study chair
Affiliated Hospital of Nanjing University of Chinese Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QingyiHuaji optimized formula in people with Pancreatic Neoplasms, run by Fudan University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: From date of randomization until the date of death from any cause, assess up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05840341, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.