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Study on the Timing Selection and Optimization of Treatment Regimens of Silybin Phospholipid Complex in Targeted and Immunotherapy

Study on the Timing Selection and Optimization of Treatment Regimens of Silybin Phospholipid Complex in Targeted and Immunotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099953
Enrollment
Unknown
Registered
2025-04-01
Start date
2025-04-01
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

The incidence of drug-induced liver injury (DILI) has been increasing year by year and has risen to the fifth leading cause of death due to liver diseases globally. Liver injury caused by anti-tumor drugs accounts for 20%-25% of DILI. China is a country with a high incidence of malignant tumors, and the incidence of tumors has shown an upward trend in recent years. Chemotherapy is currently one of

Interventions

Treatment group for 8 weeks:None
Treatment group for 4 weeks:None
Treatment group for 12 weeks:None
Initial treatment group:None

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Voluntarily sign the informed consent form; 2.The age ranges from 16 to 65 years old. 3.Newly diagnosed tumor patients who are planned to receive targeted and immunotherapy; 4.Have good compliance and be able to take medications as per the protocol and attend follow-up appointments on schedule.

Exclusion criteria

Exclusion criteria: 1.The age is less than 18 years old or more than 65 years old. 2.The liver function indicators had already shown abnormalities before receiving targeted and immunotherapy; 3.Use drugs with obvious liver damage (such as antituberculosis drugs, anti-HIV drugs, non-steroidal anti-inflammatory drugs, etc.) after the liver function test and before chemotherapy. 4.Use drugs with obvious liver damage in combination (such as antituberculosis drugs, anti-HIV drugs, non-steroidal anti-inflammatory drugs, etc.); 5.Combined with other liver treatments (such as liver radiotherapy, transarterial hepatic embolization treatment, etc.); 6.The follow-up period is less than 3 months.

Design outcomes

Primary

MeasureTime frame
Liver biochemical index;

Secondary

MeasureTime frame
Economic burden;

Countries

China

Contacts

Public ContactYingli He

The First Affiliated Hospital of Xi'an Jiaotong University

heyingli2000@xjtu.edu.cn+86 29 8532 4016

Outcome results

None listed

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