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A multicenter randomized controlled trial of "Yiqi Yangying" formulation for post-operation patients with gastric carcinoma and colonic cancer receiving combination chemotherapy

Improvement of immun function of post-operation patients with digestive tract cancer by "Yiqi Yangying" Traditional Chinese Medicine formulation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000389
Enrollment
Unknown
Registered
2009-05-04
Start date
2009-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Gastric carcinoma and colonic cancer

Interventions

Group B:FOLFOX4 course will be used: 85 mg/m2 OXA
Group A:Orally giving "Yiqi yangyin" granul from one week before the chemotherapy to the participants. 100ml water solving one bag of granul, three times a day, totally 6 weeks, to the second week aft

Sponsors

The General Hospital of Fuzhou Army District
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients with II and III stages (according to NCCN guideline 2008) gastric carcinoma and colonic cancer diagnosed by histopathology, accepted RO section treatment, without tumour focus; 2. Allow to accept the chemotherapy; 3. Aged 18 to 75; 4. KPS >=70; 5. Expected survival >=6 months; 6. Normal presentation of Blood cell count, liver function, renal function and ECG; 7. No any other tumour history, except skin cancer and cervical carcinoma; 8. Not used other anti-tumour drugs and the drugs can influence boold cell, immun function, include "Buyi" TCMs; 9. Signed consent form.

Exclusion criteria

Exclusion criteria: 1. allergic history for treatment drugs; 2. WBC=<3.5*10^9/L or neutrophillic granulocyte<1.5*10^9/L, Hb<80g/L, Plt<80*10^9/L; 3. ALT or AST higher than upper threshold 2.5 times, bilirubin concentration higher than upper threshold 2.5 times, BUN and Gr concentration than upper threshold 1.5 times; 4. Needs to be venous inject blood products such as red cell or albumin, etc. 5. Complicated with immun system diseases, or uncontrolled sever internal diseases or acute infections, life threatenning on due treatment; 6. Upper degistive tract physiological function deficiency, absorption function deficiency or unable orally take drugs; degistive tract bleeding; 7. Use other drugs during the treatment; 8. In last three monthes participated other new drug clinical trials; 9. Breast feeding or pregnancy woman; 10. Had accepted organ translation; 11. Researchers in this study.

Design outcomes

Primary

MeasureTime frame
Quality of life;Mortality;Disease free survival;Concentration of CD3+, CD4+, CD4+/ CD8+, NK cell, Immuknow, IL-2, INF-r;

Secondary

MeasureTime frame
Rate of chemetherapy;Assessment of physical strenth;

Countries

China

Contacts

Public ContactJian Du
dujian@fjtcm.edu.cn+86 0591 22861982

Outcome results

None listed

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