Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer

• Status: Completed
• Trial end date: 2022-12-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ShuGuang Hospital

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.