Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer

NCT05908838 | Completed Early Phase 1

• 1 other identifier: 42507214-11
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

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

Conditions

Gastric Cancer (Diagnosis)

Keywords

Modified Banxia Xiexin Decoction; Gastric Cancer; Clinical Efficacy; Randomized clinical trial; Mechanism

Outcome Measures

Primary Outcomes (1)

• Overall survival

  To observe the effects of treatment group and control group on OS in patients with advanced gastric cancer, and evaluate whether there is statistical difference in OS between the two groups.From date of randomization until the date of death from any cause, whichever came first, assessed up to 18 months.

  the patients' were included into the clinical trials and up to 18 weeks treatment

Secondary Outcomes (5)

• Progression-free survival

  the patients' were included into the clinical trials and up to 18 weeks treatment

• EORTC QLQ-C30

  the patients' were included into the clinical trials and up to 18 weeks treatment

• Clinical symptoms

  the patients' were included into the clinical trials and up to 18 weeks treatment

• Tumor markers

  the patients' were included into the clinical trials and up to 18 weeks treatment

• Immune function

  the patients' were included into the clinical trials and up to 18 weeks treatment

Study Arms (2)

combination chemotherapy with Modified Banxia Xiexin Decoction

ACTIVE COMPARATOR

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

Drug: Modified Banxia Xiexin Decoction

combination chemotherapy with Placebo granules

PLACEBO COMPARATOR

The control group received combination chemotherapy with Placebo granules.

Drug: combination chemotherapy with Placebo granules

Interventions

Modified Banxia Xiexin Decoction 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 Modified Banxia Xiexin Decoction

combination chemotherapy with Placebo granules DRUG

combination chemotherapy with Placebo granules

combination chemotherapy with Placebo granules

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage IV gastric cancer with a clear cytological or pathological diagnosis.
• The patient is willing to receive palliative chemotherapy (more than 6 months between the first treatment or the last chemotherapy).
• At least one measurable lesion revealed by imaging (PET-CT, CT, MRI, bone scan, x-ray).
• Expected survival of ≥ 6 months.
• It is consistent with the diagnosis of spleen qi deficiency and cold-heat mismatch in TCM.
• Age 18 to 75 years with a physical condition score of ECOG (0-1).
• The blood count is normal, heart, liver and kidney functions are not abnormal, and the electrocardiogram is basically normal.
• Patients have good compliance, are able to understand the study and sign an informed consent form.

You may not qualify if:

• Those with a history of severe cardiovascular, urinary, hematological and digestive system diseases.
• Pregnant or breastfeeding women with uncontrollable mental disorders.
• With gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia.
• Complications of serious infectious diseases such as active tuberculosis.
• Those with contraindications to chemotherapy or frequent vomiting.
• Poor compliance.
• Patients who have used other trial drugs or in other clinical trials in the past month.

Sponsors & Collaborators

• ShuGuang Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms; Disease

Interventions

Drug Therapy, Combination

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Mingyu Sun, doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: January 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 2, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06