Combining Traditional Chinese Medicine with Standard Chemotherapy for Advanced Pancreatic Cancer

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 study is testing if adding a traditional Chinese herbal formula to standard chemotherapy can help people with advanced pancreatic cancer live longer and feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 306 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: radiation, chemotherapy, immunotherapy
• Locations: 4 sites (Beijing, Beijing and 3 other locations)
• Trial ID: NCT05840341 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of the QingyiHuaji optimized formula in conjunction with standard chemotherapy for patients with stage IV pancreatic ductal adenocarcinoma. It is a multicenter, randomized controlled trial involving 306 participants who will be divided into an experimental group receiving the herbal formula and a control group receiving a placebo. The primary endpoint is overall survival, while secondary endpoints include progression-free survival, quality of life, and symptom relief. The study aims to assess whether the addition of traditional Chinese medicine can improve treatment outcomes for this challenging cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed stage IV pancreatic ductal adenocarcinoma and an expected survival of more than 3 months.

Not a fit: Patients with earlier stages of pancreatic cancer or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance survival rates and quality of life for patients with advanced pancreatic cancer.

How similar studies have performed: While traditional Chinese medicine has been explored in various contexts, this specific combination with standard chemotherapy for advanced pancreatic cancer is relatively novel.

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.

Where this trial is running

Beijing, Beijing and 3 other locations

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Not_yet_recruiting)
• Affiliated Hospital of Nanjing University of Traditional Chinese Medicine — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
• Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Hao Chen, professor

Conditions Pancreatic Neoplasms; Traditional Chinese Medicine