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Clinical study for the treatment of gastric cancer by Banxiaxiexin decoction combined with chemotherapy: a randomized controlled trial

Clinical and basic study for the treatment of gastric cancer by Banxiaxiexin decoction: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020702
Enrollment
Unknown
Registered
1990-01-01
Start date
2019-01-20
Completion date
Unknown
Last updated
2019-01-28

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

Conditions

Gastric Cancer

Interventions

Test Group:chemotherapy+Banxiaxiexin decoction
Control Group:chemotherapy

Sponsors

Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age ranges from 18 to 75 years (including 18 and 75 years), and gender is not limited. 2. Subjects need to meet one of the following two conditions: (1) Pathological cytology and/or histology confirmed palliative or neoadjuvant radiotherapy and chemotherapy for advanced gastric cancer or esophagogastric junction cancer, and at least one measurable lesion displayed by imaging examination (PET-CT, CT, MRI, bone scan, gastroscopy); (2) Adjuvant chemotherapy for gastric cancer or esophagogastric junction cancer confirmed by pathological cytology and/or histology: ? T2N0M0 with high risk factors (age < 40 years old; high or low histological grade; infiltration of nerve bundles or blood vessels or lymphatic vessels); ? T3-4 NanyM0; ? TanyN+M0; ? R0 excision. 3. The general condition of patients was good, ECOG (0-2). 4. TCM syndromes belong to the miscellaneous syndromes of cold and heat. 5. Blood routine, heart, liver and kidney function, cardiac ultrasonography, coagulation function, electrocardiogram and other indicators are in line with the treatment indications. 6. Voluntarily accept the observation of this research plan, with good compliance, clear thinking, clear expression and normal language and sensory response. 7. 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. 7. Have a history of organ transplantation.

Design outcomes

Primary

MeasureTime frame
Progression free survival;Disease free survival;

Secondary

MeasureTime frame
Overall survival;TCM syndromes points;Immune function;Quality of life;Safety;Intestinal flora;metabonomics;

Countries

China

Contacts

Public ContactLiu Ningning

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

liuningning689@126.com+86 021 20256433

Outcome results

None listed

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