Real-world Study of Dedifferentiated Liposarcoma Patients in China

Demographic, Clinical Characteristics, and Treatment Outcomes Associated With Dedifferentiated Liposarcoma Patients in China

This study will characterize patients with dedifferentiated liposarcoma (DDLPS) in China, including an understanding of demographic, and clinical characteristics as well as treatment patterns and clinical outcomes associated with the current real-world treatment.

Study Overview

• Status: Completed
• Conditions: Dedifferentiated Liposarcoma

• Study Type: Observational
• Enrollment (Actual): 1390

Contacts and Locations

Study Locations

• China
  • Beijing, China, 102208
    • Beijing Jishuitan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) network on or after January 1, 2013 and confirmed dedifferentiated liposarcoma (DDLPS).

Description

Inclusion criteria:

• Patient has two or more documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) network on or after January 1, 2013.
• Patient has a confirmed diagnosis of dedifferentiated liposarcoma (DDLPS) during his/her lifetime.
• At least 18 years old at the date of initial diagnosis.

No exclusion criteria are applied.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
DDLPS patients with 1L treatment at index date (Cohort 1); Patients with unresectable locally advanced or metastatic differentiated liposarcoma (DDLPS) who received at least one line of systemic antineoplastic treatment by the end of cohort identification period (index date = start date of first line (1L) treatment).
DDLPS patients without 1L treatment at index date (Cohort 2); Patients with DDLPS who have not initiated 1L systemic antineoplastic treatment by the end of cohort identification period (index date = date of initial DDLPS diagnosis during cohort identification period). Patients who initiated 1L treatment afterwards or patients who received adjuvant and/or neoadjuvant therapy only through follow-up were included in Cohort 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Overall Survival	Overall survival (OS) as an event for each patient in Cohort 1 was defined as the date of death minus the index date or the start day of each line of therapy (LOT). For patients with no record of death, OS was censored at the last activity date before the end of the study period.	Time from index date until the earliest record of death or end of the study period, up to 10 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1, Cohort 2: Survival After Initial Diagnosis	Survival after initial diagnosis for each patient was defined as the date of death minus the date of initial diagnosis. For patients with no record of death, survival after initial diagnosis was censored at the last activity date before the end of the study period.	Time from initial diagnosis until the earliest record of death or end of the study period, up to 10 years.
Cohort 1, Cohort 2: Total Number of Treatment Lines	The total number of treatment lines in both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.	At index date and during follow-up, up to 10 years.
Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type	Number of patients with first line (1L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.	At index date and during follow-up, up to 10 years
Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type	Number of patients with second line (2L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.	At index date and during follow-up, up to 10 years
Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type	Number of patients with third line (3L) therapy by treatment type for both cohorts is reported. Lines of therapy (LOT) were defined by the temporal relationship and sequencing of treatment regimens by using the dates of initiation and discontinuation of chemotherapy, targeted therapy, and/or immunotherapy.	At index date and during follow-up, up to 10 years
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Steroid Therapy	Number of patients who received treatments with drugs classified as concurrent steroid therapy for both cohorts is reported.	At index date and during follow-up, up to 10 years
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Concurrent Immunosuppressant Therapy	Number of patients who received treatments with drugs classified as concurrent immunosuppressant therapy for both cohorts is reported.	At index date and during follow-up, up to 10 years
Cohort 1, Cohort 2: Number of Patients With Treatments Classified as Hormone Replacement Therapy	Number of patients who received treatments with drugs classified as hormone replacement therapy for both cohorts is reported.	At index date and during follow-up, up to 10 years

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Adipose Tissue; Liposarcoma
• Other Study ID Numbers: 1403-0024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No