Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer

NCT ID: NCT05908838

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2022-12-02

Brief Summary

Research purpose To elucidate the effect mechanism and clinical effective of Modified Banxia Xiexin Decoction 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 Modified Banxia Xiexin Decoction's treatment on gastric cancer

Detailed Description

Modified Banxia Xiexin Decoction 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 Modified Banxia Xiexin Decoction in the treatment gastric cancer Therapeutic Schedule#In this study, 146patients 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, 73 patients in the Modified Banxia Xiexin Decoction combined chemotherapy group and 73 patients in the Placebo granules combined chemotherapy group.Modified Banxia Xiexin Decoction group was treated with 18 weeks of Chinese patent medicine Modified Banxia Xiexin Decoction at the same time of chemotherapy. The Overall survival, Progression-free survival, Solid tumor efficacy, TCM syndrome score, quality of life score, Tumor markers, Immune function and adverse reactions of the two groups before and 18 weeks after treatment were observed and compared. Elucidate the possible mechanism of action of Modified Banxia Xiexin Decoction in the treatment of gastric cancer patients.

Conditions

Gastric Cancer (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combination chemotherapy with Modified Banxia Xiexin Decoction

146 patients with gastric cancer were randomly divided into a treatment group of 73 cases and a control group of 73 cases. The treatment group received combination chemotherapy with Modified Banxia Xiexin Decoction

Group Type: ACTIVE_COMPARATOR

Modified Banxia Xiexin Decoction

Intervention Type: DRUG

The treatment group#Modified Banxia Xiexin Decoction group#was given Modified Banxia Xiexin Decoction, 2 bags each time, 2 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 S-1 monotherapy regimen.

combination chemotherapy with Placebo granules

The control group received combination chemotherapy with Placebo granules.

Group Type: PLACEBO_COMPARATOR

combination chemotherapy with Placebo granules

Intervention Type: DRUG

combination chemotherapy with Placebo granules

Interventions

Modified Banxia Xiexin Decoction

The treatment group#Modified Banxia Xiexin Decoction group#was given Modified Banxia Xiexin Decoction, 2 bags each time, 2 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 S-1 monotherapy regimen.

Intervention Type: DRUG

combination chemotherapy with Placebo granules

combination chemotherapy with Placebo granules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with stage IV gastric cancer with a clear cytological or pathological diagnosis.

2. The patient is willing to receive palliative chemotherapy (more than 6 months between the first treatment or the last chemotherapy).

3. At least one measurable lesion revealed by imaging (PET-CT, CT, MRI, bone scan, x-ray).

4. Expected survival of ≥ 6 months.

5. It is consistent with the diagnosis of spleen qi deficiency and cold-heat mismatch in TCM.

6. Age 18 to 75 years with a physical condition score of ECOG (0-1).

7. The blood count is normal, heart, liver and kidney functions are not abnormal, and the electrocardiogram is basically normal.

8. Patients have good compliance, are able to understand the study and sign an informed consent form.

Exclusion Criteria

1. Those with a history of severe cardiovascular, urinary, hematological and digestive system diseases.

2. Pregnant or breastfeeding women with uncontrollable mental disorders.

3. With gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia.

4. Complications of serious infectious diseases such as active tuberculosis.

5. Those with contraindications to chemotherapy or frequent vomiting.

6. Poor compliance.

7. Patients who have used other trial drugs or in other clinical trials in the past month.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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

42507214-11

Identifier Type: -

Identifier Source: org_study_id