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A randomized controlled trial of invigorating spleen and tonifying kidney and detoxifying method in the treatment of elderly patients with advanced colorectal cancer

A randomized controlled trial of invigorating spleen and tonifying kidney and detoxifying method in the treatment of elderly patients with advanced colorectal cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000625
Enrollment
Unknown
Registered
2025-04-01
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Colorectal cancer

Interventions

Control group:Quxie capsule placebo

Sponsors

Xiyuan Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age 60-85 years old both sexes; 2) Colorectal cancer diagnosed by pathology; 3) Clinical stage IV with measurable lesions; 4)ECOG 0-2; 5) predicted survival time =6 months; 6) voluntarily participate in the study and sign the informed consent; 7) Good compliance was predicted and the efficacy and adverse reactions could be followed up according to the protocol.

Exclusion criteria

Exclusion criteria: 1) patients with radical surgery or potential transformation; 2) Diarrhea > 3 times/day or grade II or above diarrhea (CTCAE v4.03); 3) Gastrointestinal bleeding fecal occult blood positive PLT < 80×109/L; 4) Severe cardiovascular system complications cerebrovascular system complications active hepatitis severe liver and kidney dysfunction; 5) There are many factors affecting the absorption of oral drugs such as inability to swallow and intestinal obstruction; 6) any unstable condition or condition that may compromise the patient's safety and adherence to the study such as severe mental illness such as schizophrenia; 7) patients who will be enrolled in or are currently enrolled in other clinical trials. (8) patients allergic to the drug. 9) Patients with unresected primary intestinal lesions and large tumor burden.

Design outcomes

Primary

MeasureTime frame
TCM related main symptoms;Progression-free survival;

Secondary

MeasureTime frame
Edmund Cancer Quality of Life Scale;Tumor markers;Median survival time;TCM spleen deficiency scale;TCM symptom score;Quality of Life instrument for colorectal cancer patients;

Countries

CHINA

Contacts

Public Contactyangyufei

Xiyuan Hospital China Academy of Chinese Medical Sciences

1821424503@qq.com13701366913

Outcome results

None listed

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