First-line Treatment of Advanced/unresectable DDLPS

Sponsor
Fudan University
Study ID
NCT06694324
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Dedifferentiated Liposarcoma
  • Soft Tissue Sarcoma (STS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Doxorubicin (Doxil) — DRUG
    30 mg/m2, d1, IV
  • Apatinib — DRUG
    250 mg, qd
  • Camrelizumab — DRUG
    200 mg, d1, IV

Study Details

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

Key Dates

Start date
Dec 1, 2024
Status verified
Sep 2024
Primary completion
Jun 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal Doxorubicin+Apatinib+Camrelizumab
    The patients with advanced or unresectable de-differentiated liposarcoma will be enrolled and given Liposomal doxorubicin hydrochloride: 30 mg/m2, d1, IV over 30 min; apatinib: 250 mg, qd; and karelizumab: 200 mg, d1, IV; Q3W, continued treatment for 6 cycles followed by apatinib and camrelizumab until disease progression, development of unacceptable toxicity, or death of the patient or 2 years of treatment.

Primary Outcome Measure

overall response rate, ORR [ Time Frame: up to two years ]

Central Contacts

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