Not Yet RecruitingPhase 2

First-line Treatment of Advanced/unresectable DDLPS

China49 participantsStarted 2024-12-01

Plain-language summary

Evaluating the efficacy and safety of liposomal doxorubicin hydrochloride and apatinib in combination with camrelizumab for the first-line treatment of advanced/unresectable dedifferentiated liposarcoma

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18-75 years, male or female;
✓. Histologically confirmed dedifferentiated liposarcoma;
✓. metastatic stage not having received systemic therapy;
✓. no brain metastases;
✓. ECOG PS: 0\~1 points;
✓. normal function of major organs, meeting the following requirements (within 7 days prior to initiation of study treatment): 1)Left ventricular ejection fraction (LVEF) ≥50%; 2)Normal electrocardiogram; 3)Hemoglobin \[HB\] ≥ 90 g/L; 4)Absolute neutrophil count \[ANC\] ≥1.5×109/L; 5) Platelet \[PLT\] ≥100×109/L; 6)Serum total bilirubin \[TBIL\] ≤1.5 times the upper limit of normal (ULN); 7) alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] \<2.5 × ULN; if there are liver metastases, ALT and AST ≤5 × ULN; 8) Serum creatinine \[Cr\] ≤ 1 × ULN or endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
✓. women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use an appropriate method of contraception for the duration of the observation period and for 8 weeks after the final administration of study drug; in the case of males, they should be surgically sterilized or agree to use an appropriate method of contraception for the duration of the observation period and for 8 weeks after the final administration of study drug;
✓. expected to have good compliance and be able to follow up on efficacy and adverse effects as required by the protocol;

Exclusion criteria

✕. patients with recurrence within six months of postoperative adjuvant therapy;
✕. previous adjuvant or neoadjuvant phase with cumulative dose of doxorubicin, liposomal doxorubicin, or other anthracyclines ≥ 240 mg/m2;
✕. Use of PD-1 or PD-L1 inhibitors in prior adjuvant or neoadjuvant phase;
✕. patients with prior adjuvant or neoadjuvant phase use of apatinib mesylate and patients with prior treatment with vascular endothelial growth inhibitor-targeted agents such as sunitinib, sorafenib, bevacizumab, imatinib, famitinib, pazopanib, regorafenib, and erlotinib.
✕. Other active malignancies within 5 years or concurrently;
✕. central nervous system involvement;
✕. clinical symptoms or diseases of the heart that are not well controlled, such as (1) cardiac insufficiency of grade II or higher according to the New York Heart Association (NYHA) criteria or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) \< 50%; (2) unstable angina pectoris; (3) myocardial infarction within 1 year prior to the start of study treatment; (4) clinically significant supraventricular or ventricular arrhythmia Need for treatment or intervention: (5) QTc \>450 ms (men); QTc \>470 ms (women) (QTc intervals are calculated using the Fridericia formula; if the QTc is abnormal, three consecutive measurements may be taken at approximately 2-minute intervals and averaged);
✕. patients with signs or history of bleeding, regardless of severity; any bleeding or bleeding event CTCAE grade 3 within 4 weeks prior to enrollment, unhealed wounds, ulcers, or fractures

What they're measuring

overall response rate, ORR

Timeframe: up to two years

Trial details

NCT IDNCT06694324

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Xin Liu, MD

0086-021-64175590 jeanettexin@hotmail.com

View on ClinicalTrials.gov More Dedifferentiated Liposarcoma trials