Clinical trial NCT05908838: Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer
Official title: Randomized Clinical Trial:Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Gastric Cancer (Diagnosis)
Keywords: Modified Banxia Xiexin Decoction
Gastric Cancer
Clinical Efficacy
Randomized clinical trial
Mechanism
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 146
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: the patients' were included into the clinical trials and up to 18 weeks treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: the patients' were included into the clinical trials and up to 18 weeks treatment
measure: EORTC QLQ-C30
timeFrame: the patients' were included into the clinical trials and up to 18 weeks treatment
measure: Clinical symptoms
timeFrame: the patients' were included into the clinical trials and up to 18 weeks treatment
measure: Tumor markers
timeFrame: the patients' were included into the clinical trials and up to 18 weeks treatment
measure: Immune function
timeFrame: the patients' were included into the clinical trials and up to 18 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: