Clinical trial NCT05888675: Clinical Study of Weifuchun Treatment on Gastric Cancer
Official title: Randomized Clinical Trial:Clinical Study of Weifuchun Treatment on Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastric Cancer (Diagnosis)
Keywords: Weifu Chun
Gastric Cancer
Clinical Efficacy
randomized clinical trial
mechanism
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients should be aged between 18 and 70 years old (including 18 and 70 years old) and their gender is not limited.
2. Pathological diagnosis of gastric malignant tumor;
3. The pathological types were adenocarcinoma, tubular adenocarcinoma, mucous adenocarcinoma and sig-ring cell carcinoma (including adenocarcinoma and some sig-ring cell carcinoma);
4. Patients were willing to receive chemotherapy (oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, or Ticeo monotherapy regimen).
5. The patient was willing to receive weifunchun treatment.

Exclusion Criteria:

1. Incomplete pathological diagnostic data;
2. Patients with severe heart, lung, liver, kidney (creatinine greater than the upper limit of the normal range), endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
3. Pregnant or lactating women, as well as pregnant persons who may not have taken effective contraceptive measures;
4. People who are allergic (allergic to two or more kinds of food, drugs, etc.) or are allergic to known ingredients of the medicine;
5. Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
6. Patients enrolled in other clinical trials within the last 1 month.

Primary outcomes:
measure: Overall survival
timeFrame: the patients' were included into the clinical trials and up to 24 weeks treatment.
Secondary outcomes:
measure: Progression-free survival
timeFrame: the patients' were included into the clinical trials and up to 24 weeks treatment.
measure: EORTC QLQ-C30
timeFrame: the patients' were included into the clinical trials and up to 24 weeks treatment.
measure: Clinical symptoms
timeFrame: the patients' were included into the clinical trials and up to 24 weeks treatment.
measure: Tumor markers
timeFrame: the patients' were included into the clinical trials and up to 24 weeks treatment.
measure: Immune function
timeFrame: the patients' were included into the clinical trials and up to 24 weeks treatment.
Other outcomes:
Locations:
Study officials:
affiliation: Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
name: Mingyu Sun, doctor
role: PRINCIPAL_INVESTIGATOR
References: