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Active, not recruitingNCT06670391Updated May 4, 2025

A Retrospective Study in Patients With Liver Injury After the Use of Novel Antineoplastic Agents

An observational study in Liver Injury and Liver Injury, Drug-Induced, sponsored by Drug Induced Liver Disease Study Group. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by Drug Induced Liver Disease Study Group · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

This is an open-enrollment, retrospective, observational study without interventions. Its primary objective is to understand 1) incidence of liver injury among all the hospitalized patient from participating centers after the administration of immune checkpoint inhibitors or molecularly targeted agents; 2) epidemiologic and clinical characteristics of liver injury, including suspected medications, clinical types, histological characteristics, severity, treatment and outcomes.

02

Conditions studied

  • Liver Injury
  • Liver Injury, Drug-Induced
03

In context

Chemical and Drug Induced Liver Injury

75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 504 across 38 observational studies indexed under Chemical and Drug Induced Liver Injury.

Browse Chemical and Drug Induced Liver Injury studies →

Lead sponsor

Drug Induced Liver Disease Study Group is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All hospitalized patients from participating medical centers.

Inclusion criteria

  • Age ≥ 18 years
  • Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor

Exclusion criteria

Exclusion Criteria:

  • Missing major baseline or clinical data
  • Prior liver loco-regional therapy or surgery
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in ALT (alanine aminotransferase)

    Absolute change

    Time frame: on day 10

Secondary outcomes

  1. Proportion of patients with normalized liver biochemistry

    Count of subjects

    Time frame: on day 3, 7, 10, 14, 21, and 30

  2. Change in liver biochemistry

    Absolute change

    Time frame: on day 3, 7, 10, 14, 21, and 30

  3. Time to normalization of liver biochemistry

    Days

    Time frame: up to 6 month

  4. Proportion of patients with ≥ 50% reduction in liver biochemistry

    Count of subjects

    Time frame: on day 3, 7, 10, 14, 21, and 30

07

Study locations

1 site
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200127, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06670391
Lead sponsor
Drug Induced Liver Disease Study Group
Responsible party
Yimin Mao (Chairman, Drug Induced Liver Disease Study Group) — Principal investigator
First posted
Nov 1, 2024
Start date
May 1, 2023
Primary completion
Apr 30, 2025
Completion
Dec 31, 2025 (estimated)
Last update
May 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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