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Post marketing safety re-evaluation and economic evaluation of sindilimab injection: based on real world data

Post marketing safety re-evaluation and economic evaluation of sindilimab injection: based on real world data

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046770
Enrollment
Unknown
Registered
2021-05-28
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-01-10

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

Conditions

Hepatocellular carcinoma

Interventions

case series:null

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Re-evaluation of safety: (1) Those who are diagnosed as malignant tumor by histological or cytological examination; (2) Received Sintilizumab injection treatment during this hospitalization. 2. Economic evaluation: (1) Patients with advanced HCC diagnosed as advanced or intolerant after receiving Sorafenib treatment and/or oxaliplatin-containing chemotherapy; (2) Received Sintilizumab injection or Carrelizumab for injection during the hospital stay.

Exclusion criteria

Exclusion criteria: 1. Re-evaluation of safety: (1) Subjects have poor compliance, which affects safety evaluators; (2) Those who have special physiological changes and are not suitable to continue the experiment; (3) Refuse to sign the informed consent form; (4) Those who have incomplete data and affect safety judgment will not be included in the final data analysis. 2. Economic evaluation: (1) Those whose subjects have poor compliance, which affects safety and efficacy evaluation; (2) Those who have special physiological changes and are not suitable to continue the experiment; (3) Refuse to sign the informed consent form; (4) Those with incomplete data that affect the judgment of safety and efficacy will not be included in the final data analysis.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse reactions/events;Clinical manifestations of adverse reactions/events;Severity of adverse reactions/events;Outcome of adverse reactions/events;Objective remission rate;Direct medical cost;

Secondary

MeasureTime frame
Risk factors of adverse reactions;Time to response;Duration of response;Progression-free survival;Quality of life (KPS score or ECoG score);

Countries

China

Contacts

Public ContactShi Chen

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

29136909@qq.com+86 15807138405

Outcome results

None listed

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