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A Clinical Study on the Efficacy and Safety of Fuzheng Jiedu Xiaoyong Granules for the Treatment of Advanced Colorectal Cancer Patients with Spleen Qi Deficiency and Blood Stasis with Toxin Syndrome

A Clinical Study on the Efficacy and Safety of Fuzheng Jiedu Xiaoyong Granules for the Treatment of Advanced Colorectal Cancer Patients with Spleen Qi Deficiency and Blood Stasis with Toxin Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002274
Enrollment
Unknown
Registered
2025-11-21
Start date
2023-08-25
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Colorectal cancer

Interventions

Experimental Group:Basic treatment + Tonifying Detoxifying Abscess-Dispersing Granules
Control Group:Basic treatment + Supportive Detoxifying and Anti-inflammatory Granules simulator

Sponsors

Liaoning University of Traditional Chinese Medicine Affiliated Second Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for colorectal cancer in Western medicine, with imaging confirming TNM staging as unresectable IIIc or IV stage, and the treatment regimen is CapOx plus bevacizumab; 2. Has at least one measurable lesion; 3. Meets the diagnostic criteria for spleen deficiency with blood stasis and toxin syndrome in traditional Chinese medicine; 4. Expected survival period of more than 6 months, with Karnofsky performance status (KPS) score >60; 5. Age between 18 and 75 years; 6. Blood tests, liver and kidney function, and other indicators meet the criteria for chemotherapy; 7. Voluntarily participates in this study and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with lesions that are resectable according to tumor TNM staging but unfit for surgery due to other reasons; 2. Patients with other severe primary diseases such as cardio-cerebrovascular, hepatic, renal, or hematopoietic system disorders; 3. Patients with allergic constitutions or hypersensitivity to the investigational drug; 4. Patients with intellectual disabilities, mental, or cognitive impairments that prevent cooperation; 5. Pregnant or breastfeeding women, or patients intending to conceive during the trial period; 6. Patients who have participated in other clinical trials within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Tumor markers (carcinoembryonic antigen, carbohydrate antigen CA19-9);T cell subsets;

Secondary

MeasureTime frame
Quality of Life Rating;Solid Tumor Efficacy Evaluation Criteria;Traditional Chinese Medicine Syndrome Scoring;

Countries

China

Contacts

Public ContactLi Guoxin

Liaoning University of Traditional Chinese Medicine Affiliated Second Hospital

syyljdlgx024@126.com13840438089

Outcome results

None listed

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