Clinical Study of Weifuchun Treatment on Gastric Cancer

NCT ID: NCT05888675

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2020-10-01

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.

Conditions

Gastric Cancer (Diagnosis)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinical Study of Weifuchun Treatment on Gastric Cancer

72 patients with gastric cancer were randomly divided into a treatment group of 36 cases and a control group of 36 cases. The treatment group received combination chemotherapy with Weifuchun tablets, while the control group received monotherapy chemotherapy.

Group Type: OTHER

Weifuchun

Intervention Type: DRUG

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.

Interventions

Weifuchun

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 Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ShuGuang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mingyu Sun

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mingyu Sun, doctor

Role: PRINCIPAL_INVESTIGATOR

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Other Identifiers

42507214-10

Identifier Type: -

Identifier Source: org_study_id