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A Clinical Study on the Regulation of the Immunomicroenvironment in Liver Cancer Patients by Si-Ni Decoction Through ß3GnT8-Mediated Cholesterol Metabolism

A Study on the Mechanism of Shenqi Decoction Polysaccharides Regulating Gut Microbiota in Liver Cancer Patients via the ß3GnT8-HMGCR-Cholesterol Metabolism Pathway

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001092
Enrollment
Unknown
Registered
2026-04-28
Start date
2022-12-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

liver cancer

Interventions

Control Group:Lenvatinib mesilate (National Drug Approval No. HJ20200044) 8 mg, qd, orally, combined with sintilimab injection (National Drug Approval No. S20180016) 200 mg IV infusion, every 3 weeks.
Experimental group:In addition to Western medical treatment, take the modified Si Ni Decoction granules (self-made granules by Suzhou Traditional Chinese Medicine Hospital, composed of 10g processed a

Sponsors

Suzhou City Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Patients who meet the diagnostic criteria of Western medicine and the criteria of syndrome differentiation in traditional Chinese medicine, aged between 18 and 75 years old; 2) At least one measurable lesion; 3) Karnofsky Performance Status (KPS) score of 60 or higher; 4) Expected survival of more than 3 months; 5) Normal results in routine blood tests, biochemical functions, and no severe impairment of heart or lung functions; 6) Child-Pugh class A or well-compensated class B (=7 points); 7) Voluntary participation in the trial, no severe drug allergies, and good compliance.

Exclusion criteria

Exclusion criteria: 1) Patients with incomplete medical documentation; 2) Patients with concurrent solid tumors or hematologic malignancies; 3) Individuals with severe systemic infections, myelosuppression, or severe cardiovascular or cerebrovascular diseases; 4) Lactating or pregnant women; 5) Patients with severe mental disorders.

Design outcomes

Primary

MeasureTime frame
gut microbiota;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Score;Quality of Life Rating;Objective Response Rate;

Countries

China

Contacts

Public ContactJingdong Gao

Affiliated Suzhou City Hospital of Traditional Chinese Medicine, Nanjing University of Chinese Medicine

gaojingdong10@163.com13913198995

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026