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

• Status: Recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

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.