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Efficacy evaluation and enrichment of population characteristics of maintenance treatment with traditional Chinese medicine for advanced gastric cancer based on leveling theory

Efficacy evaluation and enrichment of population characteristics of maintenance treatment with traditional Chinese medicine for advanced gastric cancer based on leveling theory

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000699
Enrollment
Unknown
Registered
2024-11-13
Start date
2024-11-14
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

gastric cancer

Interventions

Experimental group:Xinjia Liangfu Jianpi Yiqi Hefang Granules for oral administration

Sponsors

Dongzhimen Hospital Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Experimental group: 1) Meets the Western diagnostic criteria for advanced gastric cancer; 2) Meets the traditional Chinese medicine syndrome differentiation criteria of spleen and stomach weakness qi stagnation and blood stasis; 3) The patient has completed first-line treatment and the efficacy evaluation is complete remission partial remission or disease stability. They are about to enter the maintenance treatment stage and do not tolerate or accept Western medicine maintenance treatment including patients who have interrupted Western medicine maintenance treatment Between the ages of 18 and 80 both males and females are eligible Expected survival period is over 6 months; 6) Karnofsky score = 60 points; 7) Not participating in other clinical practices for the purpose of observing clinical efficacy; Control group: 1) Meets the Western diagnostic criteria for advanced gastric cancer; 2) The patient has completed first-line treatment and the efficacy evaluation is complete remission partial remission or disease stabil

Exclusion criteria

Exclusion criteria: Those who do not meet the inclusion criteria or although they meet the inclusion criteria have one of the following conditions as exclusion criteria: 1) those who also have primary heart brain liver kidney and hematopoietic system diseases or have serious tumor complications and comorbidities; 2) Pregnant and lactating women; 3) Individuals with allergies or known allergies to certain medications in the prescription; 4) Existence of mental illness or cognitive impairment; 5) Those who cannot take medication on time have poor compliance or cannot adhere to follow-up; 6) Merge with other primary malignant tumors

Design outcomes

Primary

MeasureTime frame
Disease Control Rate;

Secondary

MeasureTime frame
Scoring of Symptoms and Signs of Spleen and Stomach Weakness Qi Stagnation and Blood Stasis Syndrome;Lymphocyte subpopulation count;MD Anderson Symptom Inventory;Quality of Life Questionnaire of Stomach Cancer;Chinese version of the Brief Fatigue Inventory;Changes in cytokine levels;Progression free survival;

Countries

China

Contacts

Public ContactLi Hou

Dongzhimen Hospital Beijing University of Chinese Medicine

houli1203@126.com13488695608

Outcome results

None listed

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