Clinical Study of Weifuchun Treatment on Gastric Cancer
Condition: Gastric Cancer (Diagnosis)
MeSH terms: Stomach Neoplasms; Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Research purpose To elucidate the effect mechanism and clinical effective of weifuchun in the
      prevention and treatment of gastric cancer. From genes related to cell differentiation,
      proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation
      and immune escape and other possible aspects to elucidate the effective and mechanism of
      weifuchun's treatment on gastric cancer.
    

Detailed description: 
      Weifuchun Treatment and mechanism on Gastric Cancer. Main Responsibility Person: Mingyu Sun
      research center#Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese
      Medicine Trial Objective#Observe the clinical efficacy and mechanism of Weifuchun in the
      treatment gastric cancer Therapeutic Schedule#In this study, 72 patients with gastric cancer
      who received chemotherapy in the Department of Gastrointestinal Surgery and Oncology,
      Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were
      recruited and divided into groups according to random number table method, namely, 36
      patients in the Weifichun combined chemotherapy group and 36 patients in the chemotherapy
      group alone. Weichun group was treated with 24 weeks of Chinese patent medicine Weichun
      tablet at the same time of chemotherapy. The physical status score, TCM syndrome score,
      quality of life score, bone marrow suppression and tumor index of the two groups before and
      24 weeks after treatment were observed and compared.Fecal samples of the above patients
      before and after the entry and exit groups were collected, screened and submitted for
      examination. Finally, 15 cases were submitted for examination in the Weifichun combined
      chemotherapy group and chemotherapy group alone, and 10 cases were submitted for examination
      in the healthy volunteers. Miseq platform was used to conduct high-throughput sequencing and
      analysis of 16S ribosomal RNA of intestinal flora, fecal quality assessment of intestinal
      flora tested was conducted, α diversity and β diversity were analyzed, and the flora
      structure, including the level of taxonomy, family, genus, etc., were compared to analyze the
      differences in each group, and elucidate the possible mechanism of action of Weichun in the
      treatment of gastric cancer patients.
    

Intervention name(s): Weifuchun
Intervention type(s): Drug
Intervention description(s): The treatment group#Weifuchun group#was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(chemotherapy group)#Chemotherapy regimen was based on the Chinese Clinical Oncology Association Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018), including oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, and Ticeo monotherapy regimen.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weifu Chun; Gastric Cancer; Clinical Efficacy; randomized clinical trial; mechanism