Dedifferentiated LiposarcomaNCT06115681

Real-world Study of Dedifferentiated Liposarcoma Patients in China

An observational study of Dedifferentiated Liposarcoma, run by Boehringer Ingelheim at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dedifferentiated Liposarcoma
How many people: 1,390 participants
Where: 1 siteChina
Study dates: 13 Mar 2024to 15 May 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Jishuitan hospital
Beijing, 102208

Other trials in China

About this study

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

Conditions: Dedifferentiated Liposarcoma
Medical subject headings: Liposarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06115681
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Time from index date until the earliest record of death or end of the study period, up to 10 years.

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At index date and during follow-up, up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 202415 May 2024

First posted3 Nov 2023
Study start13 Mar 2024
Primary completion15 May 2024
Study completion15 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dedifferentiated LiposarcomaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 1,390 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06115681
Sponsor's protocol ID: 1403-0024
Status last verified: Jul 2025
First submitted: 27 Oct 2023
Last updated: 10 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
Active, not recruitingPhase 2
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
Metastatic Angiosarcoma, Metastatic Dedifferentiated Liposarcoma
RecruitingPhase 1/2
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Solid Tumor, Sarcoma
Active, not recruitingPhase 2
A Study of Etrumadenant and Zimberelimab in People With Dedifferentiated Liposarcoma
Dedifferentiated Liposarcoma, Soft Tissue Sarcoma

All Dedifferentiated Liposarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Demographic, Clinical Characteristics, and Treatment Outcomes Associated With Dedifferentiated Liposarcoma Patients in China
ClinicalTrials.gov ID: NCT06115681
Acronym / sponsor ID: 1403-0024
Conditions: Dedifferentiated Liposarcoma
Study type: Observational
Recruitment status: Completed
Enrolment: 1,390 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 13 Mar 2024 (actual)
Primary completion: 15 May 2024 (actual)
Study completion: 15 May 2024 (actual)
First posted: 3 Nov 2023 (actual)
Results: Posted 10 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Cohort 1: Overall Survival
Time frame: Time from index date until the earliest record of death or end of the study period, up to 10 years.
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.

8 secondary outcomes

Cohort 1, Cohort 2: Survival After Initial Diagnosis
Time frame: 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
Time frame: At index date and during follow-up, up to 10 years.
Cohort 1, Cohort 2: First Line (1L) of Therapy by Treatment Type
Time frame: At index date and during follow-up, up to 10 years
Cohort 1, Cohort 2: Second Line (2L) of Therapy by Treatment Type
Time frame: At index date and during follow-up, up to 10 years
Cohort 1, Cohort 2: Third Line (3L) of Therapy by Treatment Type
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At index date and during follow-up, up to 10 years

Results and safety

Results posted to the registry on 10 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DDLPS Patients With 1L Treatment at Index Date (Cohort 1)	275	275
DDLPS Patients Without 1L Treatment at Index Date (Cohort 2)	1,115	1,115

Primary outcome: Cohort 1: Overall Survival

Time frame: Time from index date until the earliest record of death or end of the study period, up to 10 years.. Median (95% Confidence Interval). Unit: months

Measure	DDLPS Patients With 1L Treatment at Index Date (Cohort 1) n = 275
OS after first line (1L) treatment	13.4 (12.5 to 15.3)
OS after second line (2L) treatment	11.9 (10.1 to 15.4)
OS after third line (3L) treatment	8.1 (6.0 to 18.2)

Population analysed: All patients diagnosed with dedifferentiated liposarcoma (DDLPS) who met the inclusion criteria of having at least 2 documented clinical visits in National Anti-Tumor Drug Surveillance System (NATDSS) in China on or after January 1, 2013 and aged ≥18 years at initial diagnosis. Only patients who received at least one line of systemic antineoplastic treatment by the end of cohort identification period were included in this analysis.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event information was not applicable for this study. All-cause mortality was recorded until end of the observation, up to 10 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DDLPS Patients With 1L Treatment at Index Date (Cohort 1)	0 of 0	0 of 0	175 of 275
DDLPS Patients Without 1L Treatment at Index Date (Cohort 2)	0 of 0	0 of 0	423 of 1,106

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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

Related trials for Dedifferentiated Liposarcoma

RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 1
Testing Low-Dose Common Chemotherapy (Liposomal Doxorubicin) in Combination With an Anti-Cancer Drug, Peposertib, in Advanced Sarcoma
Metastatic Dedifferentiated Liposarcoma, Metastatic Leiomyosarcoma
Active, not recruitingPhase 2
Oleclumab and Durvalumab for the Treatment of Recurrent, Refractory, or Metastatic Sarcoma
Metastatic Angiosarcoma, Metastatic Dedifferentiated Liposarcoma
RecruitingPhase 1/2
STC-15 as a Part of Combination Therapy With Toripalimab in Selected Advanced Cancers and as Monotherapy in Participants With Selected Sarcomas
Solid Tumor, Sarcoma
Active, not recruitingPhase 2
A Study of Etrumadenant and Zimberelimab in People With Dedifferentiated Liposarcoma
Dedifferentiated Liposarcoma, Soft Tissue Sarcoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dedifferentiated Liposarcoma, run by Boehringer Ingelheim at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Overall Survival (time frame: Time from index date until the earliest record of death or end of the study period, up to 10 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06115681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.