Clinical study on Banxia Xiexin Decoction Combined with palliative chemotherapy in the treatment of HER2 positive advanced gastric cancer

Not Applicable

Recruiting

• Conditions: Gastric Cancer

• Registration Number: ITMCTR2000003707
• Lead Sponsor: Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients with gastric cancer who met the diagnostic criteria and had positive HER-2 test and TNM stage IV;
2. First-line palliative chemotherapy is proposed;
3. At least one measurable lesion displayed by imaging examination (PET-CT, CT, MRI, bone scan, gastroscopy);
4. The estimated survival time is greater than or equal to 6 months;
5. TCM syndromes belong to the miscellaneous syndromes of cold and heat;
6. Age between 18 and 75 years old (including 18 and 75 years old);
7. Physical status score ECOG PS score 0-1;
8. Blood routine, heart, liver and kidney function, cardiac ultrasonography, coagulation function, electrocardiogram and other indicators are in line with the treatment indications.
9. Voluntarily accept the observation of this research plan, with good compliance, clear thinking, clear expression and normal language and sensory response.
10. Subjects were able to understand the study and sign informed consent and were willing to follow up.

Exclusion Criteria

1. Severe diseases such as heart, liver, kidney and hematopoietic system, pregnancy or lactationand uncontrollable psychosis.
2. Symptomatic brain metastases, with complications associated with brain metastasis and cognitive impairment.
3. Patients with dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation and other contraindications to the use of chemotherapeutic drugs.
4. Allergies to this drug are known.
5. Active tuberculosis and other serious infectious diseases.
6. Taking part in or taking part in clinical trials of other drugs within 4 weeks.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival;Safety;

Secondary Outcome Measures

Name	Time	Method
DCR;TCM syndromes points;ORR;Quality of life;Tumor marke;Immune function;