Post marketing safety and economic evaluation of tirilizumab injection: Based on real world data

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100042489

Enrollment

Unknown

Registered

2021-01-22

Start date

2021-03-16

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

cancer

Interventions

Safety evaluation:no

Economic evaluation (sindilimab-r / rchl group):no

Economic evaluation (Tirilizumab R /Rchl group):no

Economic evaluation (Sindilimab advanced squamous NSCLC group):no

Economic evaluation (Tirilizumab advanced squamous NSCLC group):no

Eligibility

Sex/Gender

All

Age

5 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for safety re evaluation: 1. patients with malignant tumor confirmed by histological or cytological examination; 2. patients who received tirilizumab injection during the hospitalization; 3. patients who received tirilizumab injection during the hospitalization; The inclusion criteria of economic evaluation are as follows (a) Economic evaluation of relapsed or refractory classical Hodgkin's lymphoma: 1. diagnosed as relapsed or refractory classical Hodgkin's lymphoma (R / rchl) after at least second-line systemic chemotherapy; 2. received tirilizumab injection or sindilimab injection during this hospitalization. (b) Economic evaluation of advanced squamous NSCLC: 1. the diagnosis of advanced squamous NSCLC; 2. the first-line treatment was tirizumab injection or cindilimab injection combined with chemotherapy.

Exclusion criteria

Exclusion criteria: 1. The subjects with poor compliance affected the safety evaluation; 2. the subjects with special physiological changes should not continue to accept the test; 3. the subjects with incomplete data affected the safety and efficacy judgment were not included in the final data analysis.

Design outcomes

Primary

Measure	Time frame
Objective remission rate;Incidence of ADR / AE;Severity of ADR / AE;Direct medical cost;	—

Secondary

Measure	Time frame
time to response;Duration of remission;Progression free survival;Discontinuation rate due to ADR / AE;	—

Countries

China

Contacts

Public ContactChen Shi

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