Sintilimab and Bevacizumab Biosimilar Combined With PLD in mTNBC

Sponsor
Fudan University
Study ID
NCT05386524
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • sintilimab — DRUG
    sintilimab 200mg, ivgtt，d1
  • bevacizumab biosimilar — DRUG
    bevacizumab biosimilar 15mg/kg，ivgtt d1
  • pegylated liposomal doxorubicin — DRUG
    pegylated liposomal doxorubicin 30mg/m2 d1，q3w

Study Details

To evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer

Key Dates

First listed
May 23, 2022
Start date
Jun 15, 2022
Status verified
Feb 2023
Primary completion
Mar 15, 2025
Completion
Mar 15, 2025

Study Design

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

Arms

  • Experimental: SBP group
    sintilimab 200mg, ivgtt，d1， bevacizumab biosimilar 15mg/kg，ivgtt d1， pegylated liposomal doxorubicin 30mg/m2 d1，q3w

Primary Outcome Measure

PFS [ Time Frame: 6 weeks ]

Central Contacts

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