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Synergy and attenuation of shenmai injection in the adjuvant chemotherapy for colon cancer

The clinical study on synergy and attenuation of shenmai injection in the adjuvant chemotherapy for colon cancer based on pharmacokinetics and drug metabolism genomics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCN-15005949
Enrollment
Unknown
Registered
2014-08-25
Start date
2013-02-08
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

Colon Cancer

Interventions

Shenmai treatment group:Shen Mai Injection+Colon resection +FOL FOX4 chemotherapy
Control:Colon resection+FOL FOX4 chemotherapy

Sponsors

Affiliated Hospital of Nanjing University of TCM (Jiangsu Provincial Hospital of TCM)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) colon cancer diagnosed by colonoscopy and pathology, Duke's A, B, C phase assessed by CT examination, patients with visible and resectable colon cancer; (2) 35 to 80 years old, no surgical contraindications, ECOG 0~2, no chemotherapy or radiotherapy previously; (3) no major organ dysfunction; well blood, liver, kidney and heart function; (4) patients are willing to comply with the treatment and follow-up, understand the situation of this study and informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) patients with poor cardiac function, Liver function, or kidney function; (2) patients with allergies or allergic to any study drug; (3) patients have token chemotherapy, radiotherapy, surgery or other anti-cancer therapy; (4) patients who tumor may be involved in surrounding organs by CT assessment.

Design outcomes

Primary

MeasureTime frame
the concentrations of 5-FU in plasma and tissue;The changes of endogenous metabolites in serum and tissues;the gene expression of drug-related transporters and metabolic enzymes in organization;Determinater of apoptosis, proliferation and VEGF by immunohistochemistry;

Countries

China

Contacts

Public ContactWang Guangji
guangjiwang@hotmail.com+86 025-83271176

Outcome results

None listed

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