Clinical Efficacy of QYHJ and Standard Chemotherapy in the Treatment of Advanced Pancreatic Cancer

NCT05840341 | Unknown Phase 3 DMC

• 1 other identifier: 2212267-7
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Pancreatic Neoplasms

Keywords

Pancreatic Neoplasms; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disease Free Survival

  From date of randomization until the date of first documented progression, assessed up to 24 months

Study Arms (2)

Experimental group

EXPERIMENTAL

QingyiHuaji optimized formula combined with standard treatment

Drug: QingyiHuaji optimized formula

Placebo group

PLACEBO COMPARATOR

placebo combined with standard treatment

Drug: QingyiHuaji optimized formula

Interventions

QingyiHuaji optimized formula DRUG

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.

Also known as: standard chemotherapy

Experimental group; Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (4)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Related Publications (8)

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  PMID: 33433946 BACKGROUND

• Bray 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.

  PMID: 30207593 BACKGROUND

• Sun 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.

  PMID: 32410791 BACKGROUND

• Kamisawa 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.

  PMID: 26830752 BACKGROUND

• Conroy 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.

  PMID: 21561347 BACKGROUND

• Von 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.

  PMID: 21969517 BACKGROUND

• Hua 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.

  PMID: 29129384 BACKGROUND

• Ouyang 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.

  PMID: 20683216 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Hao Chen

  Fudan University

  STUDY DIRECTOR

• Li Feng

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

• Jun Qian

  Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

  STUDY CHAIR

• Aiguang Zhao

  Shanghai University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Hao Chen, professor

CONTACT

18017312356; chengkll@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: May 3, 2023
• Study Start: May 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)