Trial Outcomes & Findings for Real-world Study of Dedifferentiated Liposarcoma Patients in China (NCT NCT06115681)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1390 participants

Primary outcome timeframe

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

Results posted on

2025-07-10

Participant Flow

This was an observational cohort study conducted to investigate patient characteristics, current treatment patterns and outcomes in Chinese patients with dedifferentiated liposarcoma (DDLPS).

Only patients diagnosed with DDLPS, who met all the inclusion criteria of having at least 2 documented clinical visits in the National Anti-Tumor Drug Surveillance System (NATDSS) on or after January 1, 2013, and were ≥18 years at initial diagnosis, were included.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	275	1115
Overall Study COMPLETED	275	1115
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DDLPS Patients With 1L Treatment at Index Date (Cohort 1) n=275 Participants 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) n=1115 Participants 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.	Total n=1390 Participants Total of all reporting groups
Age, Continuous	56.9 Years STANDARD_DEVIATION 11.5 • n=275 Participants	57.4 Years STANDARD_DEVIATION 11.7 • n=1115 Participants	57.3 Years STANDARD_DEVIATION 11.7 • n=1390 Participants
Sex: Female, Male Female	109 Participants n=275 Participants	495 Participants n=1115 Participants	604 Participants n=1390 Participants
Sex: Female, Male Male	166 Participants n=275 Participants	620 Participants n=1115 Participants	786 Participants n=1390 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	DDLPS Patients With 1L Treatment at Index Date (Cohort 1) n=275 Participants 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.
Cohort 1: Overall Survival OS after first line (1L) treatment	13.4 months Interval 12.5 to 15.3	—
Cohort 1: Overall Survival OS after second line (2L) treatment	11.9 months Interval 10.1 to 15.4	—
Cohort 1: Overall Survival OS after third line (3L) treatment	8.1 months Interval 6.0 to 18.2	—

SECONDARY outcome

Timeframe: Time from initial diagnosis until the earliest record of death or end of the study period, up to 10 years.

Population: 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 with an existing diagnosis date were included in this analysis.

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.

Outcome measures

Outcome measures
Measure	DDLPS Patients With 1L Treatment at Index Date (Cohort 1) n=272 Participants 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) n=1106 Participants 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.
Cohort 1, Cohort 2: Survival After Initial Diagnosis	30.3 months Interval 26.8 to 36.7	38.4 months Interval 35.0 to 42.6

SECONDARY outcome

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

Population: 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 being age ≥18 years at initial diagnosis.

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.