Skip to content

Mechanistic Exploration and Clinical Impact of Tisotumab Vedotin-Related Adverse Effects: Integrating FAERS Data Mining, Network Pharmacology, Molecular Docking, and Real-World Evidence

Mechanistic Exploration and Clinical Impact of Tisotumab Vedotin-Related Adverse Effects: Integrating FAERS Data Mining, Network Pharmacology, Molecular Docking, and Real-World Evidence

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114973
Enrollment
Unknown
Registered
2025-12-19
Start date
2025-12-20
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Malignant tumor

Interventions

Vitesoltumab observation group:None

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Applicants must be 18 years old or above, with no gender restrictions. 2.It has been pathologically confirmed as a malignant tumor and is currently receiving treatment with vitesoltumab. 3.At least one course of treatment with vitesoltumab has been completed. 4.Be able to cooperate in completing the assessment of the quality of life scale and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.There is a mental illness or cognitive dysfunction, and one is unable to complete the questionnaire independently. 2.Currently participating in other interventional clinical trials that may affect the assessment of quality of life.

Design outcomes

Primary

MeasureTime frame
The incidence rate, occurrence time, duration and severity of various adverse reactions during the treatment with vitesoltumab.;The impact of adverse reactions on the overall quality of life of tumor patients was evaluated using;

Secondary

MeasureTime frame
The proportion of treatment interruption, dose adjustment or treatment termination due to adverse reactions;The incidence of serious adverse events (SAE);

Countries

China

Contacts

Public ContactSuiwen Ye

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

airmiao@163.com+86 20 34070717

Outcome results

None listed

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