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Evaluation of Safety Measures and Management Practices for Immunotherapy for Primary Liver Cancer in Chinese Population

Safety Study of Immunotherapy for Hepatobiliary Tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085934
Enrollment
Unknown
Registered
2024-06-21
Start date
2022-05-06
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Hepatobiliary Malignancies

Interventions

Case series (Part 1):N/A
Case series (Part 2):N/A

Sponsors

Zhongshan Hospital Affiliated to Fudan University; Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Part 1: 1. Age: Male or female patients aged 18 and above 2. Primary liver cancer 3. Using immunotherapy, including a. Initial treatment stage, patients within 3 weeks of the first medication use b. In the treatment stage, patients who are receiving treatment and taking medication for 3-6 months 4. Voluntary signing of informed consent form Part 2: 1. Age: Male or female patients aged 18 and above 2. Primary liver cancer 3. Initial treatment: Receive the first dose of PD-1/PD-L1 immunotherapy for no more than 3 weeks 4. Voluntary signing of informed consent form

Exclusion criteria

Exclusion criteria: 1. Currently participating in clinical trials of other PD-1/PD-L1 drugs 2. Judged by doctors to have poor understanding or compliance, and not suitable for participating in this survey

Design outcomes

Primary

MeasureTime frame
Adverse reaction assessment scale;Quality of Life Assessment Scale (EORTC QLQ-C30);

Secondary

MeasureTime frame
Chinese Patient Immunotherapy Specific Questionnaire;

Countries

China

Contacts

Public ContactXu Li; Sun Huichuan

Sun Yat-sen University Cancer Center; Zhongshan Hospital Affiliated to Fudan University

xuli@sysucc.org.cn+86 135 2765 6798

Outcome results

None listed

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