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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003707
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

Sponsors

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Progression free survival;Safety;

Secondary

MeasureTime frame
DCR;TCM syndromes points;ORR;Quality of life;Tumor marke;Immune function;

Countries

China

Contacts

Public ContactLiu Ningning

Department of Medical Oncology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

liuningning689@126.com+86 021-20256586

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026