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First-line Treatment of Advanced/unresectable DDLPS

ConditionsDedifferentiated LiposarcomaSoft Tissue Sarcoma (STS)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years, male or female;

Histologically confirmed dedifferentiated liposarcoma;

metastatic stage not having received systemic therapy;

no brain metastases;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Liposomal Doxorubicin (Doxil)

    Drug

    30 mg/m2, d1, IV

  • Apatinib

    Drug

    250 mg, qd

  • Camrelizumab

    Drug

    200 mg, d1, IV

Treatment groups

49 Participants
are divided into 1 treatment group
Group A: Liposomal Doxorubicin+Apatinib+CamrelizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

overall response rate, ORR

the best response rate

Time frame
up to two years

Secondary outcomes

1

progression free survival, PFS

from first dose treatment to disease progression

Time frame
up to three years
2

overall survival, OS

overall survival

Time frame
up to three years
3

adverse events, AE

treatment related adverse events, TRAEs

Time frame
up to three years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: